RAPS Events


  • Indiana Chapter Webcast: Raising the Regulatory Voice – Persuasive Framing

    Jan 30, 1:00 PM - 2:00 PM
    Regulatory professionals have complicated jobs with many types of demands; tight timelines, divisional overlap and complex project plans. It’s therefore critical that regulatory professionals be persuasive, engaging and influential within their companies and health authorities. The first step in getting there is improved communication skills. When you understand your audience, you can communicate at your best. Different persuasive tactics are needed to be truly effective, clear and compelling. By learning how to apply framing techniques, identify decision-making styles and utilize resistance to your advantage, you can effectively raise your regulatory voice. At the conclusion of this presentation, participants will have a better understanding of: Persuasive tactics to improve your communications skills. Framing techniques and how they are best applied. How to identify decision-making styles and craft your arguments for them. Join us for this interactive webcast to learn new and innovative techniques to be more persuasive and influential in your communications as a regulatory professional. This activity is coordinated by the RAPS Indiana Chapter and intended to provide knowledge sharing and professional development opportunity for regulatory professionals in your region. RAC holders may claim one RAC recertification credit .

  • RAC (US) Preparation Virtual Program (Spring 2018)

    Feb 5
    5 February – 31 March 2018 The RAC (US) Prep Virtual Program provides a thorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, pharmaceuticals and biologics. Using the Fundamentals of US Regulatory Affairs book as a foundation, the program provides real-world examples and practical applications provided by regulatory experts. It also includes information about FDA regulations and employs critical thinking and analytical skills to help you better prepare for the RAC (US) exam. This virtual format offers a more flexible schedule, so you can take notes and review topics at your own pace, and includes five live Q&A sessions with regulatory experts who can provide more clarity and answer your specific questions. Dig into and revisit topic areas you need more time on, or use familiar information as a reference to brush up on your regulatory knowledge. The following topic areas are covered: General information Drugs Medical devices Biologics Other product classifications Inspection and enforcement This is a high-engagement program with different learning and study formats including: Eight weeks of lessons in a virtual classroom setting through on-demand webcasts Five live, expert-led Q&A sessions Expert regulatory facilitators Online community for virtual study groups RAC (US) practice exam Study checklist US exam content outline

  • Sponsored Webcast: How to Better Manage Quality and Risk with a Global Change Control Strategy

    Feb 21, 12:00 PM - 1:30 PM
    21 February 2018 12:00–1:30pm ET Sponsored by: Sparta Systems Change control impacts the entire product lifecycle so understanding how to build the right program to manage change can make a world of difference when it comes to product quality and patient safety. The ability to have changes tracked and managed automatically is critical to product quality. Change control affects both quality and regulatory teams, so having an electronic system in place that provides real-time alerts can be extremely helpful to manage the product lifecycle. Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success. At a Glance Date: Wednesday, 21 February 2018 Time: 12:00–1:30 pm ET Location: This program is a webcast. Registration Closes: Tuesday, 20 February 2018 Will this meeting be recorded? Yes Registration Fees: RAPS Members: Free List: Free Objectives & Audience Learning Objectives Upon the webcast's conclusion, you will be able to: Understand the necessary elements of a global change control strategy Gain insight on change control processes in emerging markets Recognize how change control supports global supply chain initiatives Leverage a risk-based approach for assessment of global supplier changes Build your plan to meet compliance requirements Learning Level: Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Who Should Attend Quality system professionals Quality assurance/quality compliance Change control specialists Validation experts Engineering Regulatory affairs professionals Speaker Katie Dowling, senior solutions consultant, Sparta Systems https://www.linkedin.com/in/katie-dowling-bb515818/ Registration Info >> Registration Online >> Registration Form (PDF) – for registration by mail or fax. Registration Closes: Tuesday, 20 February 2018 Other Information One login provided per registration. Duplicate logins will be removed from the webcast room. Individuals wishing to register after the registration deadline, may register only by phone. Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org . Program Contact Joanne Won jwon@raps.org +1 301 770 2920, ext. 242 Cancellation RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org . Substitutions may be accepted with written approval from RAPS. How Does It Work? For the best webcast experience, please use Google Chrome, Mozilla Firefox or Internet Explorer browser. RAPS Webcasts are also mobile and tablet accessible for your convenience. You will receive instructions on how to log in 48 hours prior to the start of the webcast. A live Q&A portion with the speaker(s) will follow the presentation and the on-demand recording can be accessed for up to one year.

  • Chicago Chapter: EU MDR - Clinical and PMS Requirements

    Feb 21, 5:30 PM - 8:30 PM
    On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transitional period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including: Key differences between the new regulation and the directives it replaces Data from clinical investigations vs. literature review The concept of equivalence The additional scrutiny in the pre- and post-market phase MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR How to ensure a smooth transition to MDR certification This program, hosted by Hu-Friedy Mfg. Co., LLC , is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits . Featured Speaker: Dr. Bassil Akra , vice president, global focus teams, TÜV SÜD Registration Information: RAPS Members: $30 List: $45

  • Twin Cities Chapter: Scaling a Human Factors Program According to a Medical Device’s Risk Profile an

    Feb 21, 5:30 PM - 8:30 PM
    Wednesday, 21 February 2018 5:30-8:30 pm CST Sheraton Minneapolis West Hotel 12201 Ridgedale Drive Minnetonka, MN 55305 +1 952-593-0000 Today, most medical device manufacturers have embraced human factors as both a regulatory and commercial imperative. There’s an understanding that human factors must be applied in the course of developing a Class II or Class III product, principally to (1) help ensure safe and effective use, and (2) meet FDA’s expectations and/or comply with IEC 62366-1. Manufacturers recognize that these consumer and software products have raised expectations among users that medical devices will be user-friendly. Join professionals from your region to learn how manufacturers can scale their human factors work relative to a device’s class (I, II or II), the nature of the users (e.g., clinicians, laypersons) and the market (competitive, non-competitive.) Session attendees will come away with a firm idea of the scope of human factors work that is required to satisfy regulator’s expectations, as well as how much is optional and worthwhile to boost a device’s marketability. This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate networking among regulatory personnel. A meal will be available for all attendees. RAC holders may claim two RAC recertification credits . Featured speaker: Michael Wiklund , general manager, human factors engineering, Underwriters Laboratories Registration Information: RAPS Members: $50 List: $65 *Call RAPS Customer Service at +1 301 770 2920 ext. 200 to learn about the special student registration rate.

  • Florida Chapter: Latest News on the European Medical Device Regulation

    Feb 26, 8:30 AM - 11:00 AM
    Monday, 26 February 2018 8:30–11:00 am EST Cerenovus (Formerly Codman Neurovascular) 6303 Blue Lagoon Drive, Suite #315 Miami, FL 33126 The new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) came into force May 2017, with full implementation deadlines set for May 2020 and May 2022, respectively. The MDR will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's directive on active implantable medical devices (90/385/EEC). This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business. Topics to be covered during this interactive session will include: Overview of MDR Impact of MDR on the conformity assessment process Impact of MDR on the technical documentation New clinical and post-market surveillance requirements The RAPS Florida Chapter invites you to join others from the local regulatory community to explore these changes and discuss what it means for manufacturers and regulatory professionals and explore ways to comply in this ever-changing environment. Continental breakfast will be provided, compliments of EMMA International Consulting Group Inc. , and RAC holders may claim two RAC recertification credits . Featured speaker: Jai Li , lead auditor, TÜV SÜD America, Inc. Registration Information: RAPS Members: $20 List: $30

  • DC-Baltimore Chapter: 2018 Planning and Networking Session

    Mar 1, 5:30 PM - 8:00 PM
    Thursday, 1 March 2018 5:30-8:00 pm EST RAPS Global Headquarters 5635 Fishers Lane, Suite #550 Rockville, MD 20852 Join colleagues from across the local regulatory community to gather over a light dinner and a fun, relaxed evening of networking. Engage with colleagues from industry, government and academia in a casual setting. Chapter leaders will be on hand to talk about what’s coming up in 2018 and how to get involved. There will also be break-out discussion groups on ways to deal with office politics. Let’s work together to achieve greater career success in 2018. Arrive before 6:15 pm to participate in a raffle for prizes, including the chance to win a complimentary e-book version of RAPS’ flagship publication, Fundamentals of Regulatory Affairs . The Fundamentals of Regulatory Affairs Series provides a global perspective on regulatory practices focused on pharmaceuticals, biologics and medical devices. The raffle winner can choose which region-specific version of the e-book they prefer—CAN, EU, International or US. This event is coordinated by the RAPS DC/Baltimore Chapter and is intended to promote knowledge sharing and facilitate connections among local regulatory professionals. A light meal will be available for all attendees and RAC holders may claim 1.5 RAC recertification credits . Registration Fees: Prior to 22 February 2018 RAPS Members: $15 List: $20 On or after 22 February 2018 RAPS Members: $25 List: $30

  • New York-New Jersey Chapter: Regulatory Affairs Certification (RAC) US Exam Overview

    Mar 10, 8:00 AM - 5:00 PM
    Saturday, 10 March 2018 8:00 am - 5:00 pm EST Hyatt House Bridgewater 530 US Route 22 Bridgewater, NJ 08807 If you’re thinking about taking the spring 2018 Regulatory Affairs Certification (RAC) US exam , join others from your local regulatory community for a full day that will help you prepare for the US exam. The session will be facilitated by a panel of certified regulatory professionals and is crafted to provide an overview of the exam. As a bonus, participants will have access to an online community populated by fellow program registrants and facilitators, so everyone will have an opportunity to ask questions leading up to the in-person session, and beyond. Topics covered in this interactive session will include: Drugs and biologics Medical devices GxPs/QSRs Test taking strategies We recommend you have a minimum of two to three years regulatory experience, as the content will be positioned with the expectation that attendees have a basic understanding of the regulatory profession. We also recommend that you purchase the Fundamentals of US Regulatory Affairs, 10th Edition and bring the book with you to the session. Participation in this RAC (US) session should not be your only method of exam preparation. RAPS provides many exam preparation materials which can help you develop a comprehensive study plan. This event is coordinated by the RAPS New York/New Jersey chapter and is intended to encourage knowledge sharing and community development. Continental breakfast and lunch will be provided. Onsite registration will not be available for this event and attendance is limited to 40 participants. Registration Information: Prior to 24 February 2018 RAPS Members: $100 List: $150 On or after 24 February 2018 RAPS Members: $125 List: $175

  • Wisconsin Chapter: 510(k) Basics and Beyond: Presentation and Roundtable Discussions

    Mar 13, 5:30 PM - 8:30 PM
    Tuesday, 13 March 2018 8:30–11:00 am CDT Delafield Brewhaus 3832 Hillside Drive Delafield, WI 53018 +1 262 646 7821 FDA’s premarket notification submission, or 510(k), is used widely to bring many medical devices to market in the United States. In a 510(k), sponsors submit documentation to demonstrate that the new or modified device is “substantially equivalent” to a predicate device in terms of intended use and technological characteristics. Submissions include information about the device, its labeling, how it compares to the predicate device and clinical and non-clinical test results. The RAPS Wisconsin chapter invites you to join others from the local regulatory community to participate in this interactive activity. The program will begin with a detailed presentation on the fundamentals of the 510(k) process, with valuable information for both new and seasoned professionals. Following the presentation, attendees will break out into small discussion groups to further explore all topics related to the 510(k) process. Discussion topics will include: When to use the 510(k) process The legal standards of the 510(k) process Substantial equivalence and predicate devices What to submit in a 510(k) How to manage the FDA interactive review process Don’t miss this unique opportunity to take a deep dive into the 510(k) process with your colleagues. A light meal will be available for all participants and RAC holders may claim two RAC recertification credits . Featured speaker: Adrienne R. Lenz, RAC , senior medical device regulation expert, Hyman, Phelps & McNamara P.C. Discussion Table Leaders: Lisa Baumhardt, RAC , regulatory affairs compliance program manager, Merge Healthcare, an IBM Company Robin R. Martin, MBA, RAC , co-founder and chief regulatory strategist, Kinetic Compliance Solutions, LLC Margaret (Meg) Mucha, MS, RAC, FRAPS , senior leader, RA and QA, IBM Watson Health Amy Yang, RAC , regulatory affairs manager, GE Healthcare Registration Information: Prior to 3 March 2018 RAPS Members: $35 List: $50 On or after 3 March 2018 RAPS Members: $45 List: $60

  • Atlanta Chapter: How Clinical Evaluation Report (CER) Requirements Impact Regulatory and Operational

    Mar 14, 1:00 PM - 5:00 PM
    MED DEV 2.7.1 Rev 4 is in full force. If you haven’t started the process of updating your existing CERs, you are behind the curve. MED DEV 2.7.1 Rev 4 is both more instructive and prescriptive, particularly regarding the use of evidence from equivalent devices. Please join regulatory professionals from your area to learn about the changes in MED DEV 2.7.1 Rev 4, and how these changes impact your CERs. We will discuss the key changes, additional CER content required for compliance and explore the common mistakes manufacturers make and how to avoid them. We will also discuss how the new EU MDR impacts your CERs. Learning Objectives: What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU? What are some of the most significant changes? How does it align with the changes to the new EU MDR? In what ways will demonstrating “equivalence” now be harder? How often must you update your CERs now, and what are the qualifications evaluators must have? How should you prepare for the increased notified body scrutiny? How do you perform a clinical literature review to meet the new expectations? Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus? Who Should Attend: Medical device presidents and CEOs Regulatory affairs professionals and management Quality professionals and management Clinical affairs professionals and management R&D engineers and management This event, hosted by Arnall Golden Gregory , is brought to you by the RAPS Atlanta Chapter and is intended to facilitate networking among area regulatory personnel. Light refreshments will be provided for all attendees. RAC holders may claim four RAC recertification credits . Featured Speaker: Mary Beth Henderson , vice president, regulatory affairs and quality systems, Regulatory and Clinical Research Institute (RCRI) Registration Information: Prior to 3 March 2018 RAPS Members: $30 List: $45 On or after 3 March 2018 RAPS Members: $40 List: $55

  • Twin Cities Chapter: Regulatory Career Networking Reception

    Mar 15, 4:30 PM - 8:30 PM
    Thursday, 15 March 2018 4:30–7:30 pm CDT Modist Brewing Co. 505 North Third Street Minneapolis, MN 55401 Join colleagues from your local regulatory community for an evening of networking in an informal setting. Learn about upcoming Twin Cities chapter activities and how to get more involved. Recruiters from local medical device, pharmaceutical and biotech companies have also been invited to engage with attendees about opportunities in the profession. There will be a brief presentation on resume building, including tips on how to make yours stand out. Light refreshments will be provided for all attendees and food trucks and a cash bar will be available for those interested. Don’t miss this unique opportunity to interact with other professionals from your region to learn about advancing your regulatory career. This event is coordinated by the RAPS Twin Cities chapter  and is intended to facilitate connections and knowledge sharing amongst the local regulatory community.

  • Chicago Chapter: Understanding Language Compliance for Global Markets

    Mar 21, 5:30 PM - 8:30 PM
    Wednesday, 21 March 2018 5:30 – 8:30 pm CDT AbbVie Inc. One North Waukegan Road Building AP 30, Lower Level Conference Room B North Chicago, IL 60064-6220 +1 800 255 5162 Join colleagues from your local regulatory community for an evening of networking and to hear an expert presentation on the importance of language compliance when registering products on the global market. Regulatory affairs professionals must understand language compliance to guide their company’s global product registrations and enable a successful market entry. Established and emerging regional regulatory frameworks continually evolve and often impose language requirements that can leave room for interpretation. This challenge, if not addressed beforehand, can cause delays during product registration and impact the success of product launches. Join others from your local regulatory community to explore the insights and experiences from the perspective of a Language Service Provider (LSP) working with regulatory teams in the pharmaceutical and medical device industries. Learn more about language compliance and answers to the most common questions that regulatory professionals face. At the conclusion of the presentation, you will have a better understanding of: What language compliance encompasses How to ensure language compliance for different audiences (regulatory authority vs. product end user) What to anticipate for regional markets with multiple languages This event is coordinated by the RAPS Chicago chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits . Featured speaker: Sheena Dempsey , managing director and CEO, RWS Life Sciences Registration Information: RAPS Member: $30 List: $45

  • Sponsored Webcast: Preparing for MDSAP Audit Success

    Mar 22, 11:00 AM - 12:30 PM
    22 March 2018 11:00am – 12:30pm ET Sponsored by: MasterControl Many medical device manufacturers are preparing for their initial Medical Device Single Audit Program (MDSAP) audit conducted by an Auditing Organization (AO) against the requirements of the MDSAP model and, potentially, multiple jurisdiction requirements. Quality assurance and regulatory affairs representatives are concerned about being adequately prepared for a successful outcome, as Health Canada’s deadline of January 2019 is fast approaching. The lack of adequate preparation and focus could lead to unnecessary nonconformities being detected with consequent certification delays and risks to market access. This webcast features four leading experts: an ex-regulator responsible for leading the design of MDSAP; a manufacturer that has already successfully completed multiple MDSAP audits; and AOs that are actively auditing MDSAP compliance. Learn top-tips for preparing and eliminating risk from your plans. Engage in a Q&A session to help refine your preparations for first-time MDSAP success. Learning Levels: Basic : Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities. Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Confidently prepare for audits under MDSAP Access other sources of detailed MDSAP information Identify key gaps in your MDSAP preparations Who Should Attend Regulatory, compliance and quality staff involved in preparing for and hosting MDSAP audits Speakers Kim Trautman, executive vice president, NSF Connie Hoy, executive vice president, Hologic Patricia Murphy, global head of MDSAP programs, BSI Healthcare Brian Ludovico, executive director, NSF Health Sciences

  • Atlanta Chapter: 2018 Southeast Regional Regulatory Career Day

    Mar 28, 1:00 PM - 7:00 PM
    Wednesday, 28 March 2018 1:00-7:00 pm EST Georgia Institute of Technology Parker H. Petit Institute for Bioengineering and Bioscience 315 Ferst Drive NW Atlanta, GA 30332-0001 Resolutions and goal setting cross everyone’s mind when a new year begins. If one of your to-do list items for 2018 is to seek exciting career opportunities in regulatory affairs, come join us for the 2018 Southeast Region Regulatory Career Day. On Wednesday, 28 March 2018, Georgia Institute of Technology will host this interactive workshop full of presentations and panel discussions from seasoned professionals on how best to advance your career in regulatory. Whether you want to transition into regulatory affairs, are an experienced regulatory professional or a student looking for a new and exciting career, this is the career event for you. Bring your resume and come prepared to engage with hiring representatives from medical device, pharmaceutical and biotech companies from the region. Presentation topics will include: How Regulatory Affairs Certification (RAC) and advanced degrees can help your career What it is like working for industry, trade association and Notified Bodies What it takes to become a regulatory consultant Who Should Attend: Those looking to start or transition into a career in regulatory Early to mid-level professionals interested in expanding their careers Professionals exploring employment opportunities This event is brought to you by the RAPS Atlanta Chapter and is intended to facilitate networking among regulatory personnel. Light refreshments will be provided for all attendees and RAC holders may claim four RAC recertification credits . A full list of speakers and program agenda will be available soon. Registration information: Prior to 17 March 2018 Student: $10* RAPS Members: $20 List: $30 On or after 17 March 2018 Student: $10* RAPS Members: $30 List: $40 *The student registration rate is not available online. Contact RAPS customer service at +1 301 770 2920 ext. 200 to acquire that rate.

  • Twin Cites Chapter: Modifications 510(k): Deciding When to Submit for a Change to an Existing Device

    Mar 29, 5:30 PM - 8:30 PM
    Thursday, 29 March 2018 5:30-8:30 pm CDT St. Cloud State University at Plymouth 9750 Rockford Road, Room #101 Plymouth, MN 55442 +1 763 496 6080 With innovation, change is a constant for medical devices. For devices brought to market by FDA’s premarket notification, or 510(k) process, careful evaluation of design and labeling changes are necessary to ensure these changes are submitted for 510(k) clearance before they are introduced. In late 2017, FDA released a revised, final guidance document related to evaluation of changes to existing devices. They also released a new, final guidance for evaluation of software changes. This presentation will provide an overview of these new guidance documents and share information on how to evaluate the changes to determine significance and how to document the regulatory evaluation of design changes. This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees and RAC holders can claim two RAC recertification credits . Featured speaker: Adrienne Lenz, RAC , senior medical device regulation expert, Hyman, Phelps & McNamara P.C. Registration Information: RAPS Member: $30 List: $45 Call RAPS Customer Service at +1 301 770 2920 ext. 200 to learn about the special student registration rate.

  • Introduction to Electronic Regulatory Submissions in the eCTD Format-April 2018

    Apr 10, 9:00 AM - 3:00 PM
    Introduction to Electronic Regulatory Submissions in the eCTD Format 10 April 2018 (9:00 am–4:00 pm PST) 11 April 2018 (9:00 am–3:00 pm PST) New Horizons Learning Center San Diego, CA 92126 Do you need to comply with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: Different submission types Which applications need to be submitted electronically How to understand and follow the CTD structure How to use the M4 series of guidances and granularity to generate compliant submissions Agency-compliant PDF files and how to generate them Which agency guidelines and technical specifications publishers need to follow What tools are required to electronically submit your applications Join us for this two-day, training that will answer your eCTD questions and help you get on a direct path to compliance. Program Dates : 10-11 April 2018 Meeting Location: New Horizons Learning Center 7480 Miramar Road #202 San Diego, CA 92126 Registration Closes : 3 April 2018 Refund Deadline : 11 March 2018 RAC Credits : 8 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 12 March 2018 RAPS Members: $1,250 Nonmembers: $1,350 Registration from 13 March 2018 RAPS Members: $1,350 Nonmembers: $1,450 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives After this program, participants will be able to: Understand the acronyms and terms surrounding electronic submissions Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD Identify best practices with software used to generate electronic submission content Produce MS Word and PDF documents that meet FDA guidelines Obtain a basic understanding of what is required to transition into submitting in the eCTD format Who Should Attend The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the fast-approaching FDA electronic submission deadlines for eCTD in May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation. Agenda Define important terminology used in e-submissions Provide a detailed breakdown of the CTD structure Understand the M4 guidances (ICH) and FDA Technical Specifications Learn how to create FDA-compliant MS Word documents Learn how to create FDA-compliant PDF documents from differing sources Review the workflow process using planners to produce an eCTD Learn how to convert from a paper application to an eCTD application Learn the basics of managing an electronic submissions project Review the entire Lifecycle of an electronic submission from first steps to eCTD Learn tips, tricks and best practices What does eCTD readiness mean? NOTE: Program content may vary. Faculty Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Registration Info NOTE: The training facility will provide each student with computers for this program. Registration to 12 March 2018 RAPS Members: $1,250 Nonmembers: $1,350 Registration from 13 March 2018 RAPS Members: $1,450 Nonmembers: $1,550 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 11 March 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Area Airports San Diego International Airport (18 miles) Area Hotels The following hotels are located near the New Horizons Training Center. San Diego Marriott La Jolla 4240 La Jolla Village Drive La Jolla, California 92037 USA Reservations: 1-858-587-1414 Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California, USA, 92122 Reservations: 1-858-552-1234 Holiday Inn Express & Suites San Diego-Sorrento Valley 5925 Lusk Blvd. San Diego, California 92121 USA Reservations: 1-858-731-0100 Cancellation All cancellation requests must be submitted to raps@raps.org by 11 March 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 27 March 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS. RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing. Supporting documentation is required and must be received by the posted deadline. All refunds are subject to a 20% assessment unless otherwise specified. Please send your cancellation information, with documentation, the name of the person registered, customer (or member) number and event title via email, to raps@raps.org . Substitutions may be accepted with written approval from RAPS.

  • Boston Chapter: Clinical Consideration for EU Regulation 2017/745

    Apr 10, 5:30 PM - 8:30 PM
    On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage with professionals from your local regulatory community for this interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including: Key differences between the new regulation and the directives it replaces Data from clinical investigations vs. literature review The concept of equivalence The additional scrutiny in the pre- and post-market phase MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR How to ensure a smooth transition to MDR certification This event is coordinated by the RAPS Boston Chapter and is intended to encourage knowledge sharing and community development. Continental breakfast will be provided, compliments of EMMA International Consulting Group. RAC holders may claim two RAC recertification credits . Registration Information: Prior to 30 March RAPS Members: $55 List: $70 On or after 30 March RAPS Members: $65 List: $80 Featured Speaker: Dr. Frank Turner, podiatric surgeon-foot-ankle orthopedics, clinical reviewer, TÜV SÜD America Inc

  • Sponsored Webcast: Steps to a Successful Advisory Committee Meeting

    Apr 11, 12:00 PM - 1:30 PM
    11 April 2018 12:00–1:30pm ET Sponsored by: 3DCommunications Presenting before an FDA Advisory Committee can be one of the most important – and most stressful --milestones in a product’s development. Good data alone are no longer enough to win approval. In today’s environment, companies must prepare a clear and persuasive presentation based on the data. They must also know how to answer the committee’s challenging questions in a credible and confident way. Most companies are ill-equipped to prepare for this daunting meeting alone. This webcast will provide you with proven steps used in more than 150 advisory committee meetings, to prepare your team and optimize your success. Learning Levels: Basic : Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities. Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Understand the essential steps necessary to be successful at an FDA Advisory Committee or Device Panel meeting. Create a realistic schedule / timeline to prepare for an FDA Advisory Committee or Device Panel meeting. Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee or Device Panel meeting. Who should attend Regulatory professionals Clinical professionals Medical Affairs professionals Communications professionals Speaker Chris Miller, MS is a biostatistician who brings experience in the design, analysis, and interpretation of clinical trials to 3D Communications’ clients. Miller leverages statistical expertise with excellent communications skills to integrate complex data with key messages. He guides teams to present data effectively for regulatory submissions and FDA advisory committee meetings. Prior to joining 3D Communications, Miller was a senior biostatistician at NAMSA, providing strategic consulting for medical device companies in the areas of study design, data analysis, regulatory submissions, and FDA negotiations. He has published more than a dozen manuscripts in peer-reviewed medical journals.

  • Intermediate Course for Regulatory Submissions in eCTD Format–April 2018

    Apr 12, 9:00 AM - 3:00 PM
    Intermediate Course for Regulatory Submissions in eCTD Format 12 April (9:00 am–4:00 pm PST) 13 April (9:00 am–3:00 pm PST) New Horizons Learning Center San Diego, CA 92126 If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements, this course is for you. Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: How to comply with the May 2018 electronic submissions requirements Which agency guidelines and technical specifications publishers need to follow How to apply ICH and regional requirements to your eCTD How to compile documents into the XML backbone of an eCTD, and lifecycle that application How to QC and validate an eCTD How metadata and study tagging files work Tips, tricks and best practices gathered from industry professionals How convert from a paper application to an eCTD How the new Module 1 (version 3.3) can be used for regulatory submissions What CTD readiness really We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ. Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance. Program Dates : 12-13 April 2018 Meeting Location: New Horizons Learning Center 7480 Miramar Road #202 San Diego, CA 92126 Registration Closes : 5 April 2018 Refund Deadline : 13 March 2018 RAC Credits : 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 14 March 2018 RAPS Members: $1,350 Nonmembers: $1,450 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives At the conclusion of this program, participants will be able to: Identify best practices with software used to generate electronic submission content Understand the acronyms and terms surrounding eCTD and electronic submissions Apply ICH and regional requirements for the content of an eCTD submission Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA. Obtain an understanding of what is required to transition into submitting in the eCTD format. Who Should Attend This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. Agenda How to comply with the May 2018 electronic submission requirements Guidances that govern electronic submissions How to electronically submit to FDA Generating compliant PDF files—best practices in MS Word and Adobe Acrobat Hands-on compilation of an eCTD Module 1 differences between US and Rest of World Creating the initial sequence of an application Assigning the metadata required by the regional authority and ICH Lifecycling the application Publishing and validating the application Compiling will include: Study Tagging Files (STFs) Datasets SPLs (Structured Product Labeling) Granulated Clinical Study Reports (gCSR) Challenges with preparing compliant eCTD submissions Review and QC of the compiled application Common and avoidable errors that could get your submission rejected Tips, tricks and best practices gathered from industry professionals Converting from a paper application to an eCTD application What eCTD readiness really means NOTE: Program content may vary. NOTE: The training facility will provide each student with computers for this program. Faculty Elsmari Eggers , head of training and RA consulting, LORENZ Life Sciences Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Jared Lantzy , PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Registration Info IMPORTANT: The training facility will provide each student with computers for this program. Attendees may bring their own laptops, but all exercises will take place on the computers supplied by the training center. Registration to 5 April 2018 RAPS Members: $1,450 Nonmembers: $1,550 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 13 March 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Area Airports San Diego International Airport (18 miles) Area Hotels The following hotels are located near the New Horizons Training Center. San Diego Marriott La Jolla 4240 La Jolla Village Drive La Jolla, California 92037 USA Reservations: 1-858-587-1414 Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California, USA, 92122 Reservations: 1-858-552-1234 Holiday Inn Express & Suites San Diego-Sorrento Valley 5925 Lusk Blvd. San Diego, California 92121 USA Reservations: 1-858-731-0100 Cancellation All cancellation requests must be submitted to raps@raps.org by 13 March 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 29 March 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org . NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • New York/New Jersey Chapter: Update on GDUFA II

    Apr 19, 5:30 PM - 8:30 PM
    Thursday, 19 April 2018 5:30-8:30 pm EST Hyatt House Branchburg 3141 Route 22 East Branchburg, NJ 08876 +1 908 704 2191 Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe and high quality generic drugs and products. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. Topics to be covered will include: What’s new with GDUFA II Pre-ANDA program Expeditated/priority review Review program enhancement Review status update POST CRL meetings Requests for reconsideration Implementation of GDUFA II Implementation meetings with FDA Year-to-date metrics and results Recommendations for success What to do when not receiving expected feedback The RAPS New York/New Jersey chapter invites you to join others from the local regulatory community to explore this important topic with your colleagues. Light refreshments will be available to all attendees. RAC holders may claim two RAC recertification credits . Featured speaker: Scott Tomsky, MS , vice president, generics regulatory affairs, North America, Teva Pharmaceuticals Registration Information: RAPS Member: $35 List: $50

  • The Basics of 510(k) and Working With FDA

    Apr 24
    Most medical devices in the U.S. today are marketed under the premarket notification (510(k) authorities of the U.S. Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most types of Class II devices in the United States, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of the regulatory fundamentals; practical guidance on how to develop, prepare, and submit a 510(k) to FDA; and how to engage with FDA. At a Glance Program Dates : 24 April 2018 (9:00 am–16:30 pm) 25 April 2018 (9:00 am–16:30 pm) Meeting Location: Hilton Garden Inn Custom House 1 Custom House Quay, North Dock, Dublin Ireland Hotel Website Registration Closes : 17 April 2018 Refund Deadline : 25 March 2018 RAC Credits : 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 26 March 2018 RAPS Members: $1,050 (€857.26 as of 1/17) Nonmembers: $1,150 (€938.90 as of 1/17) Registration from 27 March 2018 to 17 April 2018 RAPS Members: $1,150 (€967.81 as of 1/17) Nonmembers: $1,250 (1020.54 as of 1/17) Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives & Audience Objectives After this program, participants will be able to: Describe the regulatory framework behind FDA’s classification of medical devices Develop the underlying data and documentation needed to support a 510(k) submission Prepare a 510(k) submission with all required sections Interact confidently with FDA during the 510(k) review process Who Should Attend This program would be appropriate for individuals who have never submitted a 510(k) and those who have some experience and are looking to sharpen their skills. Agenda FDA Medical device regulatory framework and introduction to 510(k) Developing a regulatory strategy Developing underlying documentation, including biocompatibility, sterilization, software, electrical and EMC testing, bench testing Preparing your 510(k) submission Interacting with FDA during the 510(k) review process Device changes after clearance NOTE: Program content may vary. Faculty Heather Rosecrans, FRAPS , Executive Vice President, Medical Devices & Combination Products, Greenleaf Health Daniel Schultz, MD, FACS, Principal, Medical Devices and Combination Products, Greenleaf Health Donna-Bea Tillman, Ph.D., FRAPS , Team Leader and Senior Consultant, Medical Devices, Biologics Consulting Registration Info IMPORTANT: Attendees must bring their own laptops. RAPS does not provide equipment for attendees. Apple computers are discouraged. Registration to 26 March 2018 RAPS Members: $1,050 (€857.26 as of 1/17) Nonmembers: $1,150 (€938.90 as of 1/17) Registration from 27 March 2018 to 17 April 2018 RAPS Members: $1,150 (€967.81 as of 1/17) Nonmembers: $1,250 (1020.54 as of 1/17) Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. » Registration Online » Registration Form (PDF) for registration by mail or fax If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 25 March 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Logistics Contact Wessel Nieuwenweg wnieuwenweg@raps.org +33 9 67 62 61 04 Area Airport Dublin Airport is 12 kilometers from the hotel and approximately a 20 minute drive. Average taxi fare is 25 EUR and bus service is available for as little as 6 EUR. Driving Directions From the M1 continue on to the Swords Road. Follow the signs towards city centre and the hotel is located on Custom House Quay. Parking Limited parking is available at the hotel at a fee of approximately 18 EUR per day in a public car park. Additional maps and information about how to reach the hotel can be found via the following website . Taxi Making use of a taxi service is a convenient way to travel to Dublin’s city centre. Traveling from the Airport to the hotel by taxi will take approximately 20 minutes, provided that traffic conditions are reasonable, and will cost approximately 25 Euros. Taxis are readily available outside the arrival are of the Airport. Hotel Accommodation RAPS has secured a discounted room block at the Hilton Garden Inn Custom House for workshop attendees. Please mention that you are participating in the RAPS workshop on 24-25 April 2018. Check-in time is 15h00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, the client recognizes that guest rooms may not be immediately available. Baggage storage will be available. The hotel check-out time is 12.00 on the day of departure. Room Rate: € 200.00 per night (including TAX) Room Rate includes: Complimentary breakfast Free WIFI Internet for all inhouse guest Tax (VAT) Cancellation All cancellation requests must be submitted to raps@raps.org by 25 March 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 10 April 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS. #EuropeEvents

  • Sponsored Webcast: Understanding and Applying FDA’s 510(k) Modifications Guidance

    Apr 25, 12:00 PM - 1:30 PM
    25 April 2018 12:00–1:30pm ET Sponsored by: MED Institute FDA’s guidance on when to submit a 510(k) for a changed device is significant and wide-ranging in its impact. Its revision in 2017 culminated a six-year process that was sometimes tumultuous. This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it. Learning Levels: Basic : Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities. Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Understand FDA’s guiding principles for making decisions about whether a 510(k) should be submitted for a modification to a device. Understand FDA’s recommended process for making decisions about whether a 510(k) should be submitted for a modification to a device. Understand an industry perspective on the guidance. Who should attend Regulatory affairs specialists and others who make “file/no file” decisions for modifications Regulatory affairs managers Engineers, marketing professionals and other affected by “file/no file” decisions for modifications Speaker Dan Dillon is a senior regulatory scientist at MED Institute. He has worked for 30 years in the medical device industry, with 28 years of Regulatory Affairs experience. Dillon has worked on over 90 510(k)s, as well as PMA, IDE and HUD/HDE submissions. With this experience has come a broad exposure to a wide variety of medical devices: vascular and non-vascular stents, capital equipment, endoscopes, catheter-based devices, emergency medical devices, drug/device combinations, apheresis devices, software devices and ophthalmological products, to name a few. He has provided regulatory strategy, team leadership and FDA meeting coordination for numerous projects. Dillon is Regulatory Affairs Certified (RAC), a member of Cook Group’s FDA Policy Working Group and provides instruction on FDA submissions at Purdue University. Dan has a M.S. in Applied Statistics from Purdue.

  • Vancouver Chapter: Looking to the Future of Regulatory Affairs

    Apr 26, 5:30 PM - 8:00 PM
    26 April 2018 5:30-8:00 pm PST LifeScan Canada 210-4321 Still Creek Drive Burnaby, BC V5C 6S7 The world according to regulatory affairs is changing more rapidly than it ever has; there has never been a more exciting time to be involved in the industry. Join others from the local RAPS Vancouver chapter for an evening of networking and engaging discussion about regulatory. Aman Khera, an innovative drug development leader with over twenty years-experience will shine a light on what the future holds for our profession and the latest developments that regulatory professionals need to be aware of regardless of what type of organization they work for. Topics to be discussed include: Essential skills that regulatory professionals need to develop to succeed in our fast-paced industry The impact of new regulations, including the EU GDPR Brexit and its effects on manufacturers Machine learning & artificial intelligence Blockchains in industry The session will end with a lively interactive discussion, including an opportunity to give input on future chapter events and a sneak peak of what’s to come at Convergence, to be held in Vancouver this October. A light meal will be available to all meeting participants and attendees who hold the RAC may claim 2 RAC recertification credits . Featured speakers: Aman Khera , senior director, global regulatory affairs, PRA Health Sciences Registration Information: RAPS Members: $25 List: $40

  • RAC (US) Preparation Virtual Program (Summer 2018)

    May 7
    7 May–29 June 2018 The RAC (US) Prep Virtual Program provides a thorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, pharmaceuticals and biologics. Using the Fundamentals of US Regulatory Affairs book as a foundation, the program provides real-world examples and practical applications provided by regulatory experts. It also includes information about FDA regulations and employs critical thinking and analytical skills to help you better prepare for the RAC (US) exam. This virtual format offers a more flexible schedule, so you can take notes and review topics at your own pace, and includes five live Q&A sessions with regulatory experts who can provide more clarity and answer your specific questions. Dig into and revisit topic areas you need more time on, or use familiar information as a reference to brush up on your regulatory knowledge. The following topic areas are covered: General information Drugs Medical devices Biologics Other product classifications Inspection and enforcement This is a high-engagement program with different learning and study formats including: Eight weeks of lessons in a virtual classroom setting through on-demand webcasts Five live, expert-led Q&A sessions Expert regulatory facilitators Online community for virtual study groups RAC (US) practice exam Study checklist US exam content outline At a Glance Program Dates: 7 May – 29 June 2018 Registration Closes: 7 May 2018 * Refund Deadline: 30 April 2018 RAC Recertification Credits: None Will the live Q&A webcasts be recorded? Yes *Note: Access to the course content begins 30 April. Registrants after this date will be responsible for all assigned content that students are expected to cover prior to the first live Q&A Session on 22 May.

  • Transitioning to the New EU MDR and IVDR: A Workshop on Real World Implementation Experiences

    May 16, 9:00 AM - 4:30 PM
    Visit the 510(k) event pag e for more details and resources on medical device submissions. Program Dates : 16 May 2018 (9:00 am–16:30 pm) 17 May 2018 (9:00 am–16:30 pm) Meeting Location: THON Hotel EU Rue de la Loi 75 Brussels, Belgium Registration Closes : 9 May 2018 Registration Fees: Registration to 16 April 2018 RAPS Members: $750 Nonmembers: $850 Registration from 17 April 2018 to 9 May 2018 RAPS Members: $850 Nonmembers: $950 (1020.54 as of 1/17) Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. » Registration Online » Registration Form (PDF) for registration by mail or fax If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. #EuropeEvents

  • Wisconsin Chapter: The Medical Device Single Audit Program (MDSAP): Experience with the Pilot Progra

    May 16, 5:30 PM - 8:30 PM
    Wednesday, 16 May 2018 5:30–8:30 pm CDT GE Healthcare Research Park 9900 West Innovation Drive Wauwatosa, WI 53226 +1 800 437 1171 The Medical Device Single Audit Program (MDSAP) allows for a single audit covering ISO 13485 requirements and country-specific regulations for five participating countries: USA, Canada, Brazil, Australia and Japan. In Canada, MDSAP will replace the CMDCAS program and become a mandatory requirement for Class II, III and IV medical devices from 1 January 2019. With over twenty years of regulatory affairs experience managing domestic and international regulatory submissions and global compliance activities, Pamela Swatkowski is a leader in regulatory affairs, quality assurance, business development, clinical and research and development in the medical device and IVD industry. In her role as director of global regulatory affairs for Abbott Molecular, she was part of the MDSAP Pilot Program and will share her experiences and lessons learned from that program. Discussion topics will include: What is MDSAP? How does MDSAP work? How does MDSAP fit with other certifications? MDSAP Case Study and Experience in Pilot Program The RAPS Wisconsin chapter invites you to join others from the local regulatory community to participate in this interactive activity. A meal will be available for all participants and RAC holders may claim two RAC recertification credits . Featured speaker: Pamela L. Swatkowski , regulatory and compliance expert, president, PLS Consulting, LLC Registration Information: RAPS Members: $35 Nonmembers: $50

  • New York/New Jersey Chapter: Off-Label Use of FDA-Approved Drugs and Devices

    May 17, 5:30 PM - 8:30 PM
    Thursday, 17 May 2018 5:30–8:30 pm EDT PORZIO, BROMBERG & NEWMAN, P.C. 100 Southgate Parkway Morristown, NJ 07962-1997 +1 973 538 1690 In the United States, physicians may prescribe pharmaceuticals and medical devices for uses other than their approved or cleared indications. This practice is known as off-label use. For some disease states, off-label use of products is widely recognized and may even constitute the standard of care. Despite this practice, manufacturers are prohibited from promoting their products for off-label uses. In recent years, this prohibition has raised questions with respect to free speech protections, scientific exchange and an ever-evolving demand for up-to-date information by the medical community and general public. This presentation will highlight recent changes in the off-label landscape, discuss impact on promotional review practices and scientific communications and include tips to prevent regulatory and compliance violations. Topics to be covered will include: Recent changes in the off-label landscape Recent off-label court cases State law developments Recent FDA guidance Draft guidance: medical product communications that are consistent with FDA-required labeling (Jan 2017) Draft guidance: drug and device manufacturer communications with payors, formulary committees and similar entities (Jan 2017) 21st Century cures act - changes to FDAMA 114 Delay of intended use rule Impact on promotional review practices and scientific communications Hypothetical for group discussion Tips to prevent violations Examination of processes Auditing and monitoring practices The RAPS New York/New Jersey chapter invites you to join others from the local regulatory community to explore this important topic with your colleagues. Light refreshments will be available to all attendees. RAC holders may claim two RAC recertification credits . Featured speaker: Jennifer A. Romanski, Esq. , principal, PORZIO, BROMBERG & NEWMAN, P.C., Life Sciences Compliance and Regulatory Counseling Department Registration Information: RAPS Members: $35 Nonmembers: $50

  • Verification and Validation through the Medical Device Product Life Cycle and Regulatory Impact

    May 18, 8:00 AM - 3:30 PM
    Verification and validation (V&V) go together and are vital for gaining and maintaining medical device market access and in the regulatory decision-making process. The intent of V&V is to establish that the device is designed and manufactured properly for its safety and effectiveness. Validation errors are among the most cited issues on FDA 483s. Join us for this interactive workshop that will include presentations that explore V&V from various perspectives. Presentations will cover fundamentals, best practices and lessons learned on: Risk-based approaches to V&V in Medical device design, manufacturing and development Process validation – A guide to successful implementation V&V of in vitro diagnostic medical devices Regulatory decision-making processes for post-market design and process changes The final program agenda and speaker list will be available soon. Join your quality and regulatory colleagues from ASQ Biomedical Division Northern California Discussion Group (NCDG) and the RAPS San Francisco Bay Area chapter for an informative and interactive session on the impact V&V has on the medical device product lifecycle. Participation in this meeting is equivalent to 0.7 ASQ RU credits or six RAC recertification credits . Registration Information: ASQ* and RAPS Members: $175 Nonmembers: $200 *Discount code provided to ASQ members

  • Executive Development Program at the Kellogg School of Management

    May 20, 8:00 AM - 5:00 PM
    This one-of-a-kind program will challenge you and demand your best, ensuring a tangible return in investment. The knowledge you gain from this transformative program can provide immediate relevance and impact for you and your organization. Key Areas Covered The Kellogg School of Management brings together a faculty of pre-eminent scholars and educators in an exciting program specifically designed for senior-level regulatory professionals that covers the following key business areas: Decision-Making Negotiation Dispute and Conflict Management Change Management Product Positioning Values-Based Leadership Reputation Management Operations Why Executive Development? Now, more than ever, regulatory executives are required to bridge science, regulation, business and strategy. In today’s global regulatory environment, executives are moving out of their comfort zones and developing new capabilities as leaders. About Kellogg Since 1908, the Kellogg School of Management at Northwestern University has made strong leaders stronger. Business Week ranks the school third out of all business schools while the Wall Street Journal places it fifth on their list of best business schools in the United States Classes will take place at the James L. Allen Center, a state-of-the-art lakefront facility on Northwestern University’s campus in Evanston, Illinois.

  • Twin Cities Chapter: Advertising and Promotion: How to Avoid Being the Sales Prevention or Probation

    May 22, 5:30 PM - 8:00 PM
    Tuesday, 22 May 2018 5:30 - 8:00 pm CST Bad Weather Brewing Company 414 Seventh Street West St. Paul, MN 55102 +1 651 207 6627 Your job as a regulatory affairs professional is tough. You can’t be so rigid and non-creative that you don’t allow marketing and sales to sell your product. Nor can you go native and become an enabler drinking the marketing Kool-Aid. Mark DuVal, president & CEO of DuVal & Associates, will give you a primer on the topics you need to know something about and inspire you to balance your role as a reviewer of advertising and promotional materials and programs. This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees and RAC holders can claim two RAC recertification credits . Featured speaker: Mark DuVal , CEO and president, DuVal & Associates Registration Information: *Student: $15 RAPS Member: $25 Nonmember: $40 *Contact RAPS customer service at support@raps.org or +1 301 770 2920 ext. 200 for student rate.

  • Understanding the Draft Guidance on Postmarketing Safety Reporting for Combination Products – An Int

    May 31, 9:00 AM - 3:00 PM
    On 20 December 2016, FDA issued its much-anticipated Final Rule on Postmarketing Safety Reporting for Combination Products. While the rule provides several clarifications from the proposed rule, certain challenges remain with respect to effective implementation of its requirements. Offered in collaboration with the Combination Products Coalition (CPC) , this program provides the unique opportunity to work with representatives from FDA, as well as Industry veterans, to examine the Final Rule and find out what your company needs to do to be in compliance by the rule’s effective date of 19 July 2018. What to expect: You will hear directly from FDA experts regarding key takeaways from the Final Rule, the Agency’s interpretation of the applicable requirements, and other important topics to anyone who works in this space. This is your chance to work through any questions you might have about the Final Rule, and let FDA know where additional gaps may exist. Working in small groups facilitated by Industry experts from the CPC, you will use a case study approach to explore concepts from the Final Rule, identify best practices for effective implementation, and note areas where additional clarity from FDA would be beneficial. The findings from these case study sessions will be presented to the broader audience, including FDA, and will be topics for discussion in a closing roundtable session. Don’t miss this crucial opportunity to provide input on these pivotal issues that could affect you for years to come. Program date: 31 May 2018 Meeting location: Amgen Inc. 601 13th Street, NW, Suite Washington, DC 20005 Registration closes: 24 May 2018 Refund deadline: 17 May 2018 RAC dredits: 7 RAC recertification credits upon completion of the program. Will this meeting be recorded? No Proof of attendance: An electronic letter of attendance will be sent upon request. Registration fees: Registration to 24 May 2018 RAPS Members: $150 Nonmembers: $150 Advance registration is required for this workshop and participants are encouraged to register early. RAPS is unable to process onsite registrations. If it is your preference, please use the registration form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solution Center at +301.770.2920, ext. 200. Objectives Understand key takeaways from the Final Rule and best practices for risk management. Assess challenges to effective implementation and address remaining gaps. Discuss potential solutions and recommendations that will require FDA and industry collaboration. Who should attend This program is intended for individuals working at all professional levels in the drug, device, biologic, and combination product space. Anyone involved in post-market safety, pharmacovigilance, medical device reporting, and all other quality, regulatory, or compliance issues will greatly benefit from attending. Agenda Examining the final rule and draft guidance Understanding the draft guidance--an industry perspective Case study, session 1 Case study, session 2 Review of case study findings Panel discussion NOTE: Program content may vary. Faculty Khaudeja Bano, MD – senior medical director, postmarket safety working group, chair, Abbott Diagnostics Melissa Burns, program coordinator, office of combination products, US FDA Isaac Chang – supervisory biomedical engineer, office of medical products and tobacco, US FDA John (Barr) Weiner – general attorney, office of combination products, US FDA Maureen Melvin – supervisory health science, office of surveillance and epidemiology, US FDA Craig Zinderman – center for biologics evaluation and research, US FDA Other information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program contact Nichelle Sankey nsankey@raps.org +301 770 2920, ext. 291 Parking There are several parking garages that are close to the Amgen office. The building is also served by the Washington Metro Area Transit rail system; the closest station is Metro Center. Delegates may also opt to take a taxi which can be hailed from your hotel, or curbside. Area airports Ronald Reagan Washington National Airport (10 miles) Washington Dulles International Airport (36 miles) Baltimore-Washington International Airport (37 miles)

  • WEBCAST: Understanding the Draft Guidance on Postmarketing Safety Reporting for Combination Products

    May 31, 9:00 AM - 3:00 PM
    On 20 December 2016, FDA issued its much-anticipated Final Rule on Postmarketing Safety Reporting for Combination Products. While the rule provides several clarifications from the proposed rule, certain challenges remain with respect to effective implementation of its requirements. Offered in collaboration with the Combination Products Coalition (CPC) , this program provides the unique opportunity to work with representatives from FDA, as well as Industry veterans, to examine the Final Rule and find out what your company needs to do to be in compliance by the rule’s effective date of 19 July 2018. What to expect: During the webcast you will hear directly from FDA experts regarding key takeaways from the Final Rule, the Agency’s interpretation of the applicable requirements, and other important topics to anyone who works in this space. This is your chance to work through any questions you might have about the Final Rule, and let FDA know where additional gaps may exist. Working in small groups facilitated by Industry experts from the CPC, you will use a case study approach to explore concepts from the Final Rule, identify best practices for effective implementation, and note areas where additional clarity from FDA would be beneficial. The findings from these case study sessions will be presented to the broader audience, including FDA, and will be topics for discussion in a closing roundtable session. Don’t miss this crucial opportunity to provide input on these pivotal issues that could affect you for years to come. Program date : 31 May 2018 Meeting location: Amgen Inc. 601 13th Street, NW, Suite Washington, DC 20005 Registration closes : 30 May 2018 Refund deadline : 17 May 2018 RAC credits : 7 RAC recertification credits upon completion of the program. Will this meeting be recorded? No Proof of attendance: An electronic letter of attendance will be sent upon request. Registration fees: Registration to 30 May 2018 RAPS Members: $150 Nonmembers: $150 Advance registration is required for this workshop and participants are encouraged to register early. RAPS is unable to process onsite registrations. If it is your preference, please use the registration form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solution Center at +301.770.2920, ext. 200. Objectives Understand key takeaways from the Final Rule and best practices for risk management. Assess challenges to effective implementation and address remaining gaps. Discuss potential solutions and recommendations that will require FDA and industry collaboration. Who should attend This program is intended for individuals working at all professional levels in the drug, device, biologic, and combination product space. Anyone involved in post-market safety, pharmacovigilance, medical device reporting, and all other quality, regulatory, or compliance issues will greatly benefit from attending. Agenda Examining the final rule and draft guidance Understanding the draft guidance-an industry perspective Case study, session 1 Case study, session 2 Review of case study findings Panel discussion N OTE : Program content may vary. Faculty Khaudeja Bano, MD – senior medical director, postmarket safety working group, chair, Abbott Diagnostics Melissa Burns, program coordinator, office of combination products, US FDA Isaac Chang – supervisory biomedical engineer, office of medical products and tobacco, US FDA John (Barr) Weiner – general attorney, office of combination products, US FDA Maureen Melvin – supervisory health science, office of surveillance and epidemiology, US FDA Craig Zinderman – center for biologics evaluation and research, US FDA Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program contact Nichelle Sankey nsankey@raps.org +301 770 2920, ext. 291 Parking There are several parking garages that are close to the Amgen office. The building is also served by the Washington Metro Area Transit rail system; the closest station is Metro Center. Delegates may also opt to take a taxi which can be hailed from your hotel, or curbside. Area airports Ronald Reagan Washington National Airport (10 miles) Washington Dulles International Airport (36 miles) Baltimore-Washington International Airport (37 miles)

  • DC/Baltimore Chapter Seventh Annual Mid-Atlantic Regulatory Career Day

    Jun 2, 9:30 AM - 4:00 PM
    Saturday, 2 June 2018 9:30 am-4:00 pm EDT Johns Hopkins University Montgomery County 9605 Medical Center Drive, Room #121 Rockville, MD 20850 +1 301 294 7000 Join your regulatory, quality and compliance colleagues from the east coast for the Seventh Annual Mid-Atlantic Regulatory Career Day, brought to you by the DC/Baltimore chapter and Johns Hopkins Advanced Academics program . This inventive workshop is designed to help you get started or advance your career in the regulatory field. Participate in this hands-on experience and hear presentations and panel discussions from seasoned professionals on topics like: The pros and cons of working for government Strategies for finding and applying for regulatory positions, government and industry What is it like to be a consultant Working for a company or academia Throughout the day, attendees can sign up for five-minute one-on-one discussions with regulatory recruiters, including FDA, to discuss current job opportunities and submit resumes. Contact RAPS Customer Service at +1 301 770 2920, ext. 200, or email support@raps.org to register as a student. View program agenda. Registration Information: Prior to 25 May Student: $10 RAPS Member: $30 Nonmember: $45 On or after 25 May Student: $10 RAPS Member: $40 Nonmember: $55 #DC Baltimore Area Chapter

  • Florida Chapter: Clinical Considerations for EU Regulation 2017/745

    Jun 4, 8:00 AM - 11:00 AM
    Monday, 4 June 2018 8:00-11:00 am EDT Cerenovus (Formerly Codman Neurovascular) 6303 Blue Lagoon Drive Suite #315 Miami, FL 33126 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage with professionals from your local regulatory community for breakfast and an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including: Key differences between the new regulation and the directives it replaces Data from clinical investigations vs. literature review The concept of equivalence The additional scrutiny in the pre- and post-market phase MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR How to ensure a smooth transition to MDR certification This event is coordinated by the RAPS Florida chapter and is intended to encourage knowledge sharing and community development. Continental breakfast will be provided and RAC holders may claim two RAC recertification credits . Featured Speaker: Matthias Fink, MD , clinical reviewer, TÜV SÜD Clinical Centre of Excellence Registration Information: RAPS Members: $25 Nonmembers: $35 #DC Baltimore Area Chapter

  • New York/New Jersey Chapter: Latest News on the European Medical Device Regulation

    Jun 7, 5:30 PM - 8:30 PM
    Thursday, 7 June 2018 5:30-8:30 pm EST Stryker Orthopaedics – Homer Stryker Center Building 325 Corporate Drive Mahwah, NJ 07430 The new European Medical Device Regulations (MDR) came into force May 2017, with full implementation deadlines set for May 2020. The MDR will replace the EU's current Medical Device Directive and understanding the new regulation is critical to manufacturers doing business in the European Union. This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes as well as determine the impact on their business. The New York/New Jersey chapter invites you to join others from the local regulatory community to explore these changes, discuss what it means for manufacturers and regulatory professionals and explore ways to comply in this ever-changing environment. Light refreshments will be available to all attendees. RAC holders may claim two RAC recertification credits . Featured speaker:  Robert Lally , senior director, regulatory affairs, Stryker Joint Replacement Division Registration information: RAPS Members: $25 List: $35 #New York New Jersey Area Chapter

  • Webcast: RAPS Member Business Meeting

    Jun 12, 12:00 PM - 1:00 PM
    12 June 2018 12:00–1:00pm EDT Join us for the virtual RAPS Member Business Meeting via webcast on Tuesday, 12 June. RAPS leaders will review organizational strategic priorities and provide updates on RAPS news and activities in 2017 and to date in 2018. Covered topics will include membership trends and engagement, new initiatives and resources, organizational finances and our work to ensure the continued relevance of the RAC credential. In addition, you will get an exclusive preview of the 2018 Regulatory Convergence and have the opportunity to participate in a live Q&A. Questions also may be submitted in advance via email to regex@raps.org . Learning Objectives Upon the webcast's conclusion, you will be able to: Know RAPS’ strategic priorities Be updated on RAPS’ recent and current activities, and finances Know what to expect at the 2018 Regulatory Convergence Who should attend RAPS members Speakers Susumu Nozawa, RAC, FRAPS, chairman of the board Don Boyer, BSc, RAC, FRAPS, president Glenn N. Byrd, MBA, RAC, president-elect Salma Michor, PhD, MSc, MBA, CMgr, RAC, treasurer Paul Brooks, executive director Bill McMoil, vice president of finance, IT and operations Speaker bios can be found here : https://www.raps.org/who-we-are/board-of-directors/raps-board-of-directors

  • Indiana Chapter: Clinical Consideration for EU Regulation 2017/745

    Jun 13, 5:30 PM - 8:00 PM
    Wednesday, 13 June 2018 5:30-8:00 pm CDT The Rathskeller Restaurant 401 East Michigan Street Indianapolis, IN 46204 +1 317 636 0396 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage with professionals from your local regulatory community for breakfast and an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including: Key differences between the new regulation and the directives it replaces Data from clinical investigations vs. literature review The concept of equivalence The additional scrutiny in the pre- and post-market phase MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR How to ensure a smooth transition to MDR certification This event is coordinated by the RAPS Indiana chapter and is intended to encourage knowledge sharing and community development. Refreshments will be available for all attendees and RAC holders may claim two RAC recertification credits . Featured Speaker: Matthias Fink, MD , clinical reviewer, Clinical Centre of Excellence at TÜV SÜD Registration Information: RAPS Members: $25 Nonmembers: $40

  • Texas Chapter: What’s Hiding in Your Labeling Artwork? What You Can’t See Can Hurt You.

    Jun 29, 6:30 PM - 8:00 PM
    Friday, 29 June 2018 6:30-8:00 pm CDT Emergo by UL Headqauarters Austin, TX 78746 +1 512 327 9997 Did you know that there are risks hiding in your labeling artwork documents that are invisible to anyone doing manual proofreading? Few are introducing these risks on purpose, of course. Graphic designers who work in-house or as third-party contractors for Life Sciences organizations, face professional challenges unique to the industry. Not only do they need to create top notch visuals, but they also need a deep understanding of the regulatory environment in which they operate. Because it’s not realistic to assume that all graphic designers will follow all regulatory best practices, it’s helpful to understand how to find these hidden risks and how to prevent them in the future. This presentation will help you understand: What the most common labeling artwork hidden risks are How and why these risks get introduced How to check your documents for these risks Best practices that can help you prevent these risks from being introduced in the future This event is brought to you by the RAPS Texas chapter and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees and RAC holders can claim two RAC recertification credits . Featured speaker: Dan Vuksanovich, MM, MBA , regional sales manager, Schlafender Hase Registration Information: RAPS Member: $25 Nonmember: $40

  • Texas Chapter: Understanding Key Aspects of the MDR

    Jul 20, 6:00 PM - 8:00 PM
    Friday, 20 July 2018 6:00-8:00 pm CDT Emergo, a UL Company 2500 Bee Cave Road Building One, Conference Room B120 Austin, TX 78746 +1 512 327 9997 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent requirements for medical device manufacturers, regardless of classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including: Device classification Conformity assessment Safety and performance requirements Technical documentation This event is brought to you by the RAPS Texas chapter and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees. RAC holders can claim two RAC recertification credits . Featured speaker: Ibim Tariah, PhD , technical director, BSI Inc. Registration Information: RAPS Members: $25 Nonmembers: $40

  • Introduction to Electronic Regulatory Submissions in the eCTD Format-July 2018

    Jul 24, 9:00 AM - 3:00 PM
    Introduction to Electronic Regulatory Submissions in the eCTD Format 24 July 2018 (9:00 am–4:00 pm EST) 25 July 2018 (9:00 am–3:00 pm EST) US Pharmacopeial Convention Rockville, MD 20852 Do you need to comply with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: Different submission types Which applications need to be submitted electronically How to understand and follow the CTD structure How to use the M4 series of guidances and granularity to generate compliant submissions Agency-compliant PDF files and how to generate them Which agency guidelines and technical specifications publishers need to follow What tools are required to electronically submit your applications Join us for this two-day, training that will answer your eCTD questions and help you get on a direct path to compliance. Program Dates : 24-25 July 2018 Meeting Location: US Pharmacopeial Convention 12601 Twinbrook Parkway Rockville, MD 20852 Registration Closes : 17 July 2018 Refund Deadline : 24 June 2018 RAC Credits : 8 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 25 June 2018 RAPS Members: $1,250 Nonmembers: $1,350 Registration from 26 June 2018 RAPS Members: $1,350 Nonmembers: $1,450 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives After this program, participants will be able to: Understand the acronyms and terms surrounding electronic submissions Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD Identify best practices with software used to generate electronic submission content Produce MS Word and PDF documents that meet FDA guidelines Obtain a basic understanding of what is required to transition into submitting in the eCTD format Who Should Attend The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the fast-approaching FDA electronic submission deadlines for eCTD in May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation. Agenda Define important terminology used in e-submissions Provide a detailed breakdown of the CTD structure Understand the M4 guidances (ICH) and FDA Technical Specifications Learn how to create FDA-compliant MS Word documents Learn how to create FDA-compliant PDF documents from differing sources Review the workflow process using planners to produce an eCTD Learn how to convert from a paper application to an eCTD application Learn the basics of managing an electronic submissions project Review the entire Lifecycle of an electronic submission from first steps to eCTD Learn tips, tricks and best practices What does eCTD readiness mean? NOTE: Program content may vary. Faculty Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Registration Info NOTE: The training facility will provide each student with computers for this program. Registration to 25 June 2018 RAPS Members: $1,250 Nonmembers: $1,350 Registration from 26 June 2018 RAPS Members: $1,450 Nonmembers: $1,550 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 24 June 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Parking Paid parking is available in the parking building directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention). Area Airports Ronald Reagan Washington National Airport (24 miles) Washington Dulles International Airport (36 miles) Baltimore-Washington International Airport (37 miles) Area Hotels The following hotels are located near US Pharmacopeial Convention. Even Hotel Rockville (Walking Distance) 1775 Rockville Pike Rockville, MD 20852 Reservations: +1 877 834 3613 Hilton Washington DC/Rockville Hotel (Walking Distance) 1750 Rockville Pike Rockville, MD 20852 Reservations: +1 301 468 1100 Bethesda North Marriott Hotel 701 Marinelli Road Bethesda, MD 20852 Reservations: +1 301 822 9200 Bethesda Marriott Suites 6711 Democracy Boulevard Bethesda, MD 20817 Reservations: +1 800 228 9290 Washington Metro Access The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station. Cancellation All cancellation requests must be submitted to raps@raps.org by 24 June 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 10 July 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Intermediate Course for Regulatory Submissions in eCTD Format–July 2018

    Jul 26, 9:00 AM - 3:00 PM
    Intermediate Course for Regulatory Submissions in eCTD Format 26 July (9:00 am–4:00 pm EST) 27 July (9:00 am–3:00 pm EST) US Pharmacopeial Convention Rockville, MD 20852 If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements, this course is for you. Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: How to comply with the May 2018 electronic submissions requirements Which agency guidelines and technical specifications publishers need to follow How to apply ICH and regional requirements to your eCTD How to compile documents into the XML backbone of an eCTD, and lifecycle that application How to QC and validate an eCTD How metadata and study tagging files work Tips, tricks and best practices gathered from industry professionals How convert from a paper application to an eCTD How the new Module 1 (version 3.3) can be used for regulatory submissions What CTD readiness really means We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ. Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance. Program Dates : 26-27 July 2018 Meeting Location: US Pharmacopeial Convention 12610 Twinbrook Parkway Rockville, MD 20852 Registration Closes : 19 July 2018 Refund Deadline : 26 June 2018 RAC Credits : 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 27 June 2018 RAPS Members: $1,350 Nonmembers: $1,450 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives At the conclusion of this program, participants will be able to: Identify best practices with software used to generate electronic submission content Understand the acronyms and terms surrounding eCTD and electronic submissions Apply ICH and regional requirements for the content of an eCTD submission Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA. Obtain an understanding of what is required to transition into submitting in the eCTD format. Who Should Attend This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. Agenda How to comply with the May 2018 electronic submission requirements Guidances that govern electronic submissions How to electronically submit to FDA Generating compliant PDF files—best practices in MS Word and Adobe Acrobat Hands-on compilation of an eCTD Module 1 differences between US and Rest of World Creating the initial sequence of an application Assigning the metadata required by the regional authority and ICH Lifecycling the application Publishing and validating the application Compiling will include: Study Tagging Files (STFs) Datasets SPLs (Structured Product Labeling) Granulated Clinical Study Reports (gCSR) Challenges with preparing compliant eCTD submissions Review and QC of the compiled application Common and avoidable errors that could get your submission rejected Tips, tricks and best practices gathered from industry professionals Converting from a paper application to an eCTD application What eCTD readiness really means NOTE: Program content may vary. NOTE: The training facility will provide each student with computers for this program. Faculty Elsmari Eggers , head of training and RA consulting, LORENZ Life Sciences Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Jared Lantzy , PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Registration Info IMPORTANT: The training facility will provide each student with computers for this program. Attendees may bring their own laptops, but all exercises will take place on the computers supplied by the training center. Registration to 19 July 2018 RAPS Members: $1,450 Nonmembers: $1,550 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 26 June 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 252 Parking Paid parking is available in the parking building directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention). Area Airports Ronald Reagan Washington National Airport (24 miles) Washington Dulles International Airport (36 miles) Baltimore-Washington International Airport (37 miles) Area Hotels The following hotels are located near US Pharmacopeial Convention. Even Hotel Rockville (Walking Distance) 1775 Rockville Pike Rockville, MD 20852 Reservations: +1 877 834 3613 Hilton Washington DC/Rockville Hotel (Walking Distance) 1750 Rockville Pike Rockville, MD 20852 Reservations: +1 301 468 1100 Bethesda North Marriott Hotel 701 Marinelli Road Bethesda, MD 20852 Reservations: +1 301 822 9200 Bethesda Marriott Suites 6711 Democracy Boulevard Bethesda, MD 20817 Reservations: +1 800 228 9290 Washington Metro Access The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station. Cancellation All cancellation requests must be submitted to raps@raps.org by 26 June 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 12 July 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org . NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Chicago Chapter: 510(k) Basics and Beyond

    Jul 26, 5:30 PM - 8:30 PM
    Thursday, 26 July 2018 5:30-8:30 pm CDT AbbVie One 26525 North Riverwoods Boulevard First Floor, San Paulo Conference Room Mettawa, IL 60045 +1 800 255 5162 FDA’s pre-market notification submission, also known as 510(k), is used widely to bring medical devices to market in the United States. In a 510(k), sponsors submit documentation to demonstrate that the new or modified device is substantially equivalent to a predicate device, in terms of intended use and technological characteristics. Submissions include information about the device, its labeling, how it compares to the predicate device and clinical and non-clinical test results. The RAPS Chicago Chapter invites you to join others from the local regulatory community to participate in interactive presentations from two subject matter experts. The program will begin with a detailed presentation on the fundamentals of the 510(k) process, with valuable information for both new and seasoned professionals. One of the speakers will also discuss their experience serving on an AdvaMed Working Group that wrote the draft 510(k) guidance document for software changes, including how the group was able to influence the Agency to use a more risk-based approach. Following the presentation, attendees will break into small discussion groups to further explore all topics related to the 510(k) process. Discussion topics will include: When to use the 510(k) process The legal standards of the 510(k) process Substantial equivalence and predicate devices What to submit in a 510(k) How to manage the FDA interactive review process An explanation of the steps in the guidance document’s decision flow chart Don’t miss this unique opportunity to take a deep dive into the 510(k) process with your colleagues. This event is coordinated by the RAPS Chicago chapter and is intended to encourage sharing your knowledge and participate in community development. Dinner will be provided and RAC holders may claim two RAC recertification credits. Featured speakers: Adrienne R. Lenz, RAC , senior medical device regulation expert, Hyman, Phelps & McNamara P.C. Christine Shumard-Sauer, RAC, PhD , director, Protocol Link, Inc. Registration Information: RAPS Members: $30 Nonmembers: $45

  • San Francisco Bay Area Chapter: EU Regulatory Affairs Certification (RAC) Exam Peer-to-Peer Study Gr

    Jul 28, 9:00 AM - 4:00 PM
    28 July and 4, 11, 18 and 25 August 2018 Each Session: 9:00 am-4:00 pm PDT University of California Santa Cruz, Silicon Valley Extension in Santa Clara 3175 Bowers Avenue Santa Clara, CA 95054 +1 408 861 3700 Are you planning to take the EU Regulatory Affairs Certification (RAC) exam this fall? Want to jump start on studying for the spring 2019 exam? Interested in learning more about the changing regulatory environment in Europe? RAPS San Francisco Bay Area Chapter invites you to participate in a series of peer-led study sessions to help you prepare for the exam and get the extra knowledge you are looking for. This study group consists of a series of five in-person sessions, hosted by our partner University of California Santa Cruz, Silicon Valley Extension in Santa Clara . Each session will include presentations from certified regulatory professionals who will provide guidance on medical device and medicinal products. Attendance of each session is the responsibility of the participant and registration is non-transferable.It is highly recommended that registrants possess a minimum of two to three years regulatory experience, as the session will be geared towards those that have at least a basic understanding of the regulatory profession. The primary resource used during each session will be RAPS’ flagship study tool, Fundamentals of EU Regulatory Affairs, Eight Edition . Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages, and study group registrants are encouraged to purchase the publication to help prepare for the exam. While a light meal will be provided for lunch at each session, breakfast will not be available. Registration Information: RAPS Members: $150 Nonmembers: $200

  • RAC (US) Preparation Virtual Program (Autumn 2018)

    Aug 1
    1 August – 28 September 2018 The RAC (US) Prep Virtual Program provides a thorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, pharmaceuticals and biologics. Using the Fundamentals of US Regulatory Affairs book as a foundation, the program provides real-world examples and practical applications provided by regulatory experts. It also includes information about FDA regulations and employs critical thinking and analytical skills to help you better prepare for the RAC (US) exam. This program will be utilizing the Fundamentals of US Regulatory Affairs 9 th edition because the current RAC exam covers regulations up to the 9 th edition of the publication. This virtual format offers a more flexible schedule, so you can take notes and review topics at your own pace. The program includes six live Q&A sessions with regulatory experts who can provide more clarity and answer your specific questions. Dig into and revisit topic areas you need more time on, or use familiar information as a reference to brush up on your regulatory knowledge. The following topic areas are covered: General information Drugs Medical devices Biologics Other product classifications Inspection and enforcement This is a high-engagement program with different learning and study formats including: Eight weeks of lessons in a virtual classroom setting through on-demand webcasts Six live, expert-led Q&A sessions Expert regulatory facilitators Online community for virtual study groups RAC (US) practice exam Study checklist US exam content outline

  • Wisconsin Chapter: The Art of Strategic Communication in Difficult Situations

    Aug 6, 5:30 PM - 8:30 PM
    Monday, 6 August 2018 5:30–8:30 pm CDT GE Healthcare Research Park 9900 West Innovation Drive Wauwatosa, WI 53226 +1 800 437 1171 Have you ever felt intimidated by the prospect of having a difficult conversation at work or in your professional life? Have you been in a position of bearing bad news that can be challenging for others to receive? If so, the RAPS Wisconsin chapter invites you to join others from your local regulatory community to hear an interactive presentation that will provide powerful strategies for how to engage in those discussions at a deeper, more connected level. Learn how facilitating healthy conflict can help ensure that those you are engaging with, will walk away feeling seen, heard and respected. By making simple shifts to your language, energy and mindset, you will have the tools to approach these challenging conversations with greater confidence, compassion and poise, which ultimately will yield greater results for you and those with whom you’re communicating with. Candy Barone is CEO & Founder of You Empowered Strong , a company that specializes in "feeding the soul of business.” She is a catalyst for bringing a new perspective to what it means to be a leader and how to build powerful, high-performing teams as a result. As an accountability powerhouse, executive coach and business strategist, Candy pulls no punches in teaching leaders how to lead from love, with love. She brings nearly 20 years of corporate experience to the table and is a master at building exceptional, high-performing teams and maximizing ROI. The RAPS Wisconsin chapter invites you to join others from your region to participate in this interactive session. A meal will be available for all participants and RAC holders may claim two RAC recertification credits . Featured speaker: Candy Barone, MBA, CCP , CEO and founder, You Empowered Strong Registration Information: RAPS Members: $35 Nonmembers: $50

  • Twin Cities Chapter: Regulatory Career and Networking Session

    Aug 13, 5:30 PM - 8:00 PM
    Monday, 13 August 2018 5:30-8:00 pm CDT Ewald Conference Center 1000 Westgate Drive St. Paul. MN 55114 +1 652 203 7243 Are you looking to transition into regulatory affairs? Maybe you’re an experienced regulatory professional exploring new career opportunities, or a student looking for a new and exciting career. If so, come join us for the Twin Cities chapter career and networking event to learn more about the opportunities in regulatory. The evening will begin with a presentation on the current challenges faced while recruiting qualified regulatory professionals. The presentation will be followed by a panel discussion of professionals sharing their experiences hiring regulatory talent. The panelist will then take questions from attendees, as we collectively explore some of the skills and experience hiring managers are looking for. The program will conclude with the opportunity for attendees to engage directly with recruiters from local regulatory companies and learn more about available opportunities. This program is coordinated by the RAPS Twin Cities chapter and is intended to facilitate professional development and networking opportunities for regulatory professionals in the region. Light refreshments will be provided for all attendees and RAC holders may claim two RAC recertification credits . Registration Information: *Student: $10 RAPS Member: $20 Nonmember: $30 *Contact RAPS Customer Service via email (support@raps.org) or telephone (+1 301 770 2920 ext. 200) for the student rate. Confirmed Panelists: Sagar Tolane, MS, PGDM , regulatory affairs specialist, Medtronic Kripa Pandya , regulatory affairs co-op, Boston Scientific Paula Norbom , independent recruiter, founder and resident, Talencio Mac McKeen, RAC, MBA , fellow, regulatory science, Boston Scientific Mike Winegar, MS , program director, MS in Regulatory Science, University of St. Thomas

  • Texas Chapter: Implementing ISO 13485:2016

    Aug 17, 6:30 PM - 8:30 PM
    Friday, 17 August 2018 6:30-8:30 pm CDT Emergo, a UL Company 2500 Bee Cave Road Building One, Conference Room B120 Austin, TX 78746 +1 512 327 9997 ISO 13485 is an internationally agreed upon standard that outlines the requirements for a quality management system (QMS) specific to the medical devices industry. The primary objective of the standard is to facilitate harmonized medical device requirements, and compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The RAPS Texas chapter invites you to come engage with your colleagues and learn how to navigate the March 2016 revisions to the standard. Learn how to implement and maintain ISO 13485:2016 to help manufacturers ensure a successful transition to the revised standard. Susan Mecca will share the key learnings, main areas of focus, tips for the transition process and an overview of how to maintain an effective management system in accordance with ISO 13485:2016, including: Software identification & validation Regulatory Authority communication Identification of critical supplier & components Maintaining technical files Risk Management This event is brought to you by the RAPS Texas chapte r and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees. RAC holders can claim two RAC recertification credits . Featured speaker: Susan Mecca, technical manager, Lloyd’s Register, Medical Device Sector Registration Information: RAPS Members: $25 Nonmembers: $40

  • Chicago Chapter: I’m Not Dead Yet: Navigating FDA’s Ever-Evolving Policies on Product Information Di

    Aug 23, 5:30 PM - 8:30 PM
    Thursday, 23 August 2018 5:30-8:30 pm CDT AbbVie Inc. 26525 N Riverwoods Blvd Chicago Room Mettawa, IL 60045 +1 800 255 5162 In 2018, the Food and Drug Administration has issued only a few enforcement letters in the area of product promotion and advertising. However, it has released guidance documents reflecting its current thinking about certain types of proactive dissemination of product information. The agency has also sent compliance letters when it has considered unlawful specific promotional activity.  During this interactive session, noted food and drug law expert, Alan Minsk, JD, will provide an overview of the following topics: FDA’s latest guidances Recently issued enforcement letters Recommendations to minimize risk Carol M Cooper MS, RAC, IM(ASCP), RM(AAM) will also provide a quick refresher with FDA guidance not easily found in the regulations, but extremely helpful in conducting communication reviews. Don’t miss this unique opportunity to learn how to navigate guidances on product advertising and promotion with your colleagues. This event is coordinated by the RAPS Chicago chapter   and is intended to encourage knowledge sharing and  community development. Dinner will be provided and RAC holders may claim two RAC recertification credits. Featured Speaker: Carol Cooper, MS, RAC, IM(ASCP), RM(AAM) , principal, CM Cooper & Associates Alan Minsk, JD , partner, Arnall Golden Gregory LLP Registration Information: RAPS Members:   $30 Nonmembers:  $45

  • Implementing the European MDR with Focus on Clinical and Supply Chain/Economic Operators

    Aug 24, 8:00 AM - 5:00 PM
    Friday, 24 August 2018 8:00 am–5:00 pm PDT Crowne Plaza San Jose-Silicon Valley 777 Bellew Drive Milpitas, CA 95035 +1 408 321 9500 On 5 May 2017, the European Commission officially published the Medical Device Regulations (MDR) 2017/745 in the Official Journal of the European Union (OJEU). The MDR replaces the Active Implantable Medical Devices Directive (90/385/EEC) and the Medical Devices Directive (93/42/EEC) . The deadline to comply with the new regulations is 26 May 2020. Come learn from our expert panel of industry representatives who have been personally involved in implementing the MDR at their organization. You’ll leave this experience with practical tips and tools needed to effectively transition to the MDR based on their lessons learned. Scheduled presentations will include: Summary of Key MDR Changes Implementing the MDR Supply Chain and Economic Operators in Practice Implementing the MDR Clinical Data Evaluation Requirements in Practice Managing Global, Cross-Functional Interactions for a Successful MDR Implementation Speaker bios and the full program agenda are available for review. Don’t miss out on this unique opportunity to hear from industry experts on this important topic while connecting with others from your region. This event is brought to you by the RAPS San Francisco Bay Area Chapter and is intended to facilitate networking and knowledge sharing amongst those in the local regulatory community. RAC holders can claim six RAC recertification credits . Speakers and Panelists: Keith Morel , vice present of regulatory compliance, QServe Tim Ehr , Integrated Project Management Company (IPM) Nancy B. Lowe , process champion for clinical evaluation reports, W.L. Gore & Associates Nicolas Pugliano , regulatory affairs associate, W.L. Gore & Associates Registration Information: RAPS Members: $175 Nonmembers: $200

  • Indiana Chapter: Clinical Consideration for EU Regulation 2017/745

    Aug 30, 5:30 PM - 8:00 PM
    Thursday, 30 August 2018 5:30-8:00 pm EDT Hampton Inn Warsaw 115 Robmar Drive Warsaw, IN 46582 +1 574 268 2600 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your orthopedic device company navigate the higher level of scrutiny. This session will include: Overview of MDR changes with Jia Li, group leader, auditing NAM 2, MHS: When legacy products need to be evaluated Acquisition of companies with existing products on the market Difference between the EU and FDA requirements concerning technical documentation Difference between Notified Bodies Transferring challenges of products from one Notified Body to another Changes in the regulation Areas of higher expectations Overview of clinical requirements with Dr. Mattias Fink, clinical reviewer MHS: Key differences between the MDR and the MDD regarding clinical evaluation Data from clinical investigations vs. data from literature review Relevant changes regarding the demonstration of equivalence The additional scrutiny and requirements in the pre and post-market phase MEDDEV 2.7/1, Rev. 4 guidance document toward the transition from the MDD to the MDR Overview of new Instrument Reprocessing Instructions and Requirements for EU: EN ISO 17664 VS FDA What’s new and Different? What Hidden Problems with Instruments Files – How Bad is the problem? Collateral Damage This event is coordinated by the RAPS Indiana chapter and is intended to encourage knowledge sharing and community development. Dinner will be available for all attendees and RAC holders may claim two RAC recertification credits . Featured Speakers: Matthias Fink, MD , clinical reviewer, Clinical Centre of Excellence at TÜV SÜD Jia Li, MSE, MBA , team manager and lead auditor, TÜV SÜD Registration Information: RAPS Members: $35 Nonmembers: $50

  • Chicago Chapter: EU MDR – What is in Scope? The Role of Notified Bodies for Combination Products

    Sep 11, 5:30 PM - 8:30 PM
    Tuesday, 11 September 2018 5:30-8:30 pm CDT AbbVie Inc. One North Waukegan Road Building AP30, Conference Room A North Chicago, IL 60064-6220 +1 800 255 5162 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transitional period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the new standards. Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces larger scope, more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your device company navigate the higher level of scrutiny, including: What is in scope of the EU MDR? Integral Parts/Products. Article 1(8), Article 1(9), Article 1(10). How does the EU MDR modify the Medicinal Product Directive 2001/83/EC - Article 117. Special Classification Rules of the MDR. Impact on Manufacturer. Technical Documentation Assessment Process. How to ensure a smooth transition to MDR certification. This program, hosted by Abbvie, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits . Featured speaker: Dr. Bassil Akra , vice president, global focus teams, TÜV SÜD Product Service GmbH Registration Information: RAPS Member: $30 Nonmember: $45

  • Sponsored Webcast: The Preparation Process for CHMP Meetings

    Sep 12, 12:00 PM - 1:30 PM
    12 September 2018 12:00 – 1:30 pm EDT Getting a product approved by the European Medicines Agency (EMA) can be daunting, especially for companies that have little experience with this unique and complex process. Within the EMA, the Committee for Medicinal Products for Human Use (CHMP) conducts a scientific data review and recommends whether or not the drug or biologic should receive marketing authorization. This webcast will walk you through how to prepare for and manage CHMP meetings, as well as how to identify and address issues prior to submission. Learning Level Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Define the EMA review timeline Evaluate how to prepare for the four different types of CHMP meetings you may face Expert Group meeting Scientific Advisory Group (SAG) meeting Oral Explanation Pharmacovigilance Risk Assessment Committee (PRAC) meeting Discuss pre-submission activities that will help identify and avoid issues Who should attend? Companies seeking to get products approved by European Medicines Agency (EMA) Speakers Kell Cannon , principal, 3D Communications Kell Cannon brings more than 20 years of U.S. and global lifecycle and pharmaceutical marketing expertise to 3D's clients. Cannon uses his analytical and organizational skills to help clients identify the strengths and weaknesses in their data and define their competitive differentiation. He has developed rigorous processes to help clients analyze and prepare their regulatory submissions and FDA advisory committee presentations. This assistance enables companies to win approval, expedite product access and achieve competitive reimbursement. Cannon has held leadership positions at Roche, Novartis, Ciba and Merck in clinical trial strategy, label negotiations, brand positioning and advocacy development. Pete Embley , senior director, regulatory science, Voisin Consulting Life Sciences (VCLS) Pete Embley has over 20 years applied industrial and commercial biopharmaceutical experience, including seventeen years in regulatory science; working within the generic, R&D and Contact Research Organization (CRO) industries. He has a strong grounding in EU legislation and filing strategies. Embley has developed both regional and global strategic perspectives coupled with commercial acumen and experience working within multicultural project teams. His collective experience reflects a balance of regulatory experience in drug development and lifecycle management. Embley has managed several Abbreviated New Drug Application (ANDA) during his time at Ranbaxy (circa 2007) and trained/mentored regulatory inductees in the US/EU generic submission process at Chugai, Ranbaxy and PPD.

  • Twin Cities Chapter: Portfolio Planning and Project Management for the EU MDR

    Sep 13, 7:30 AM - 11:00 AM
    Thursday, 13 September 2018 7:30-11:00 am CDT Ewald Conference Center 1000 Westgate Drive St. Paul. MN 55114 +1 652 203 7243 Major changes to the EU MDR require major changes for manufacturers, including product portfolios and internal management system processes. This requires collaboration and coordination of efforts across multiple departments, each with their own requirements, perspectives and points of view, with regulatory professionals in the middle trying to manage needs, wants and regulations. Leveraging effective project management techniques can help mitigate the inevitable conflicts arising from these situations and keep the transition project on course. The first presentation of this this event will provide best practices and insights into effective project planning and project management, a skill that regulatory professionals need to have on their resume. Topics to be covered include: The top 10 most common mistakes a project manager makes Project Charters – your savior Communications - what you need to know and practice The minimum information needed for planning and why you need them Interviewing techniques for gathering project data points MDR document and data organization is critical to creating and implementing an efficient EU MDR portfolio planning process and transition plan. MDR portfolio planning begins with the process of combining technical documents and data with regulatory requirements into a manageable database. The inputs include identification of design dossiers and technical files and the FG part numbers on the corresponding DOC’s, EC certification expiration dates, planned product lifecycle management obsolescence dates, and preliminary assessment of remediation needs. All of these inputs are used to realign and reduce regulatory files, schedule remediation and file transition activities and propose portfolio plan revisions that benefit the company – considering the significant cost and resources needed to transition products to the EU MDR. The second presentation will provide real-world examples of using this process, share efficiencies gained from it and demonstrate the effective communication and alignment that can be achieved as a result. This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate professional development and networking opportunities for regulatory professionals in your region. Breakfast will be provided for all attendees and RAC holders may claim three RAC recertification credits . Featured speakers: Julie Maes , director, territory operations, Regulatory and Quality Solutions LLC Joe Perzel , president, JPerzel & Associates Registration Information: RAPS Members: $50 Nonmembers: $65

  • Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges

    Sep 19, 9:00 AM - 3:00 PM
    This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other highly regulated regions. The class is designed to orient professionals, managers and scientists responsible for biopharmaceutical CMC development and preparation of dossiers to technical issues that must be addressed in biologic product development and registration. Topics will include biological product characteristics; CMC regulations and guidance applicable to biologics; Quality by Design, adventitious agents risk management; source material, cell & seed banks; upstream and downstream processing, formulation and final product production; characterization and testing; demonstrating comparability. Program Dates: 19-20 September 2018 Registration Closes: 12 September 2018 Refund Deadline: 20 August 2018 RAC Credits: 12 (Upon attending and completing the program) Will the meeting be recorded? No Registration to 20 August 2018 RAPS Members: $1050 Nonmembers: $1150 Registration from 21 August to 21 September 2018 RAPS Members: $1150 Nonmembers: $1250 NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. Program Schedule Wednesday, 19 September (9:00 am – 4:30 pm) Types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies) Biologics/Biosimilars product characteristics and corresponding regulatory implications Biologics/Biosimilars CMC regulation and guidance framework Clinical phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars Cell substrates & source materials, cell banks Upstream processing Thursday, 20 September (9:00 am - 3:00 pm) Clinical phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued) Downstream processing Final product formulation Characterization Testing & specifications Adventitious agents risk management Validation Demonstrating comparability & comparability protocols NOTE: The agenda may vary based on changing requirements. Location US Pharmacopeial Convention 12601 Twinbrook Parkway Rockville, Maryland 20852 Faculty Patricia Cash, PhD, MedImmune, Inc. Joseph Quinn, Biologics Regulatory Consultant Program Objectives At the conclusion of this workshop, participants should: Be familiar with various types of biologic products and their structural/functional characteristics Understand development phase-appropriate Regulatory Agency expectations associated with biologics and biosimilars characterization, development, production and testing Understand best practices in establishing a comprehensive Chemistry, Manufacturing, and Control (CMC) regulatory strategy for application to the lifecycle of biologic and biosimilar products Understand Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products Translate an effective biologics CMC strategy into effective regulatory submission content for biologic and biosimilar products Who Should Attend This program will benefit early, mid-career, and senior regulatory professionals in CMC working in development, registration and post approval lifecyle management for biologic/biosimilar products. There are no prerequisites for participation. Cancellation All requests for cancellation must be received in writing or by calling customer service by 20 August 2018 . Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS. Proof of Attendance RAPS will send an electronic letter or a certificate of attendance upon request. Questions Call RAPS Solutions Center at +1 301.770.2920, Ext 200 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Registration Form If it is your preference, please use the Registration Form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. When mailing your payment, please ensure that you attach a completed registration form. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, Ext 291 Area Hotels Even Hotel Rockville 1775 Rockville Pike Rockville, Maryland 20852 Reservations: 877-834-3613 Hilton Washington DC/Rockville Hotel 1750 Rockville Pike Rockville, Maryland 20852 Telephone: 301-468-1100 Washington Metro Access Red Line to the Twinbrook Metro Station

  • Texas Chapter: Clinical Considerations For the New EU Regulations

    Sep 21, 6:00 PM - 8:00 PM
    Friday, 21 September 2018 6:00-8:00 pm CDT Emergo by UL Headquarters 2500 Bee Cave Road Building One, Conference Room B120 Austin, TX 78746 +1 512 327 9997 Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the new EU MDR. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including: Key differences between the new regulation and the directives it replaces Data from clinical investigations vs. literature review The concept of equivalence The additional scrutiny in the pre and post-market phase MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR How to ensure a smooth transition to MDR certification This event is coordinated by the RAPS Texas chapter and is intended to encourage knowledge sharing and community development. A light meal will be provided and RAC holders may claim two RAC recertification credits . Featured Speaker: Anna Calleja, MHS, cCE , cardiologist, clinical reviewer, TÜV SÜD Registration Information: RAPS Members: $25 Nonmembers: $40

  • Chicago Chapter: Regulatory Career Day

    Sep 22, 8:00 AM - 4:00 PM
    Saturday, 22 September 9:00 am - 4:00 pm CDT Vernon Township Community Center Community Service Multi-Purpose Room 2900 North Main Street Buffalo Grove, IL 60089 +1 847 634 4600 Are you looking to transition into regulatory affairs? Maybe you’re an experienced regulatory professional exploring a new career opportunity, or a student looking for a new and exciting career. If so, join your fellow regulatory, quality and compliance colleagues for the 2018 RAPS Chicago Chapter Regulatory Career Day. This full-day program will provide attendees with career development presentations from experienced professionals, access to representatives from schools with advanced degrees and certificates in regulatory and a chance to engage with recruiters about career opportunities in the profession. Scheduled presentations include: The Path from NIH to FDA to the Pharmaceutical Industry What It’s Like Working for FDA Internal Routes to the Regulatory Profession Building Strengths in the Office Space Life as a Legal Counsel What’s It’s Like Working as a Consultant The Synergy Between Quality and Regulatory Schools invited to participate include: Temple University Colle of Pharmacy RA/QA Purdue College of Technology: Biotechnology, Innovation and Regulatory Science Northwestern Regulatory Compliance and Quality Systems UIC College of Pharmacy This innovative workshop is designed to help you get started or advance your career in the regulatory field. Don’t miss this unique experience to learn more about the profession, find out about opportunities and expand your network by attending this RAPS Chicago Chapter program. Continental breakfast and lunch will be provided for all attendees and RAC holders can claim five recertification credits . Registration Information: Student: $20 RAPS Member: $35 Nonmembers: $50

  • Atlanta Chapter: Impact of the MDR Regulatory Changes on the EU Approval Process

    Sep 26, 3:00 PM - 7:00 PM
    Wednesday, 26 September 2018 3:00-6:00 pm  Educational Session 6:00-7:00 pm  Networking Reception Arbor Pharmaceuticals, LLC Five Concourse Parkway, Lobby Level Atlanta, GA 30328   The new European medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) came into force May 2017, with full implementation deadlines now set for May 2020 and May 2022, respectively. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Come join regulatory professionals from your area for a combination of educational programming and explore these changes and discuss what it means for manufacturers, regulatory professionals and how you will comply in this ever-changing environment. This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business. Immediately following this presentation, we will have a networking reception at the Westin Atlanta Perimeter North Hote l lounge, located directly next door to the meeting facility. This RAPS Atlanta chapter program is sponsored and hosted by Arbor Pharmaceuticals, LLC and is intended to facilitate networking among area regulatory personnel. Light refreshments will be provided during the educational portion of the event, with heavy hors d’oeuvres and non-alcoholic drinks available at the networking reception. RAC holders may claim three RAC recertification credits . Featured speaker: Royth v. Hahn, MS , senior vice president, TÜV SÜD Medical & Health Services Prior to 19 September: RAPS Members:  $25 Nonmembers:  $40 On or after 19 September: RAPS Members: $40 Nonmembers: $55 #AtlantaChapter

  • New York/New Jersey Chapter: The Ins and Outs of FDA Sponsor-Monitor Inspections

    Oct 18, 5:30 PM - 8:30 PM
    Thursday, 18 October 2018 5:30-8:30 pm EDT Ferring Pharmaceuticals 100 Interpace Parkway Parisippany, NJ 07054 +1 973 796 1600 The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm's compliance with applicable laws and regulations. This typically involves an investigator visiting a firm’s location. A single inspection may include multiple activities, which makes it imperative for regulatory professionals to understand the process and become familiar with the classifications. Come join others from your local regulatory community for an evening of networking and a presentation followed by an interactive question and answer session. Topics to be covered will include: History and purpose of BIMO inspections Objectives of FDA sponsor-monitor inspections FDA inspections statistics Common findings from FDA inspections Tips for hosting an FDA inspection Case studies The engagement activity, hosted by Ferring Pharmaceuticals , is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Light refreshments will be available to all attendees and RAC holders may claim two RAC recertification credits . Featured speaker: Michael A. Trapani, MS, MBA , group leader, senior consultant, Biologics Consulting Registration Information: Prior to 11 October: RAPS Member: $35 Nonmember: $50 On or After 11 October: RAPS Member: $45 Nonmember: $60 #Events

  • Sponsored Webcast: Negotiation is Another Word for Problem Solving

    Oct 23, 12:00 PM - 1:30 PM
    23 October 2018 12:00 – 1:30 pm EDT Based on research and conferences conducted by the Harvard Negotiation Project, this webcast will cover techniques and tactics of principled negotiation, illustrating how to achieve great results while being decent and fair with colleagues or health authorities. Principled negotiation requires discipline and tact - it pushes hard on the merits of proposals while preserving relationships. It employs no tricks or posturing; negotiation is channeled into a problem-solving conversation. Being a skilled negotiator is particularly important for regulatory professionals, interacting with a wide variety of teams, divisions, health authorities, etc – all with different objectives and concerns. Improve your negotiation skills in this webcast by learning to probe the interests of the other party, acknowledge feelings, listen actively, ask revealing questions, seek options for mutual gain and understand that the most powerful interests are basic human needs. Learning Level Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Understand negotiation and communication techniques to pursue win-win outcomes Present information or ideas with diplomacy and authority Harness the power of experts in your negotiations to strengthen your hand Handle difficult negotiation tactics, questions or audiences Who should attend? Anyone negotiating agreements with internal development teams, external collaborators or health authorities Anyone that needs to use negotiations to influence without direct management authority Anyone tasked to facilitate discussion and agreement between differing parties Speaker Frank Carillo , ceo, ECG Frank originally learned negotiation principles and techniques at the Wharton School of Business. Throughout his career, he’s demonstrated how communication strategy empowers people to build the explanations and advocacy necessary. Frank has worked with clients who present new drug applications to the Food and Drug Administration’s Advisory Committee meetings for approval and commercial release. Under his direction, ECG has supported over 165 FDA AdComms, including numerous first-in-class approvals across a wide variety of therapeutic areas and many Marketing Authorization Application approvals (including Oral Explanations and Scientific Advisory Groups) with the European Medicines Agency.

  • Boston Chapter and ASQ New England Discussion Group of the Biomedical Division : China Food and Drug

    Oct 24, 3:00 PM - 7:00 PM
    Wednesday, 24 October 2018 3:00-7:00 pm EST The Conference Center at Waltham Woods 860 Winter Street Waltham, MA 02451 +1 781 437 7499 Don’t miss this unique opportunity to engage with regulatory and quality colleagues from your region for an in-depth exploration of major restructuring at the China Food and Drug Administration (CFDA.) Several members of the CFDA staff, including an interpreter, will be in attendance to interact with attendees and answer questions. Our esteemed speaker, subject matter expert, Grace Fu Palma, just returned from a CFDA meeting in China. She will provide an overview of major restructuring at CFDA and other 2018 updates. This half-day program will include three sessions, each targeted to regulatory, quality and CRO professionals. Scheduled presentations include: CRO Update: Overview of Recent Clinical Requirement Changes and Looking Ahead to 2019 Clinical Evidence Requirements Clinical Trial/Evaluation International Clinical Data Multi-Center Trial Quality Update: QMS and Post-market Compliance Changes Overseas Inspections Summary of History Lessons Tips and Processes to Prepare for Oversees Inspections Regulatory Update: Pathways to Foreign Companies Innovation, Special Zones and Type Testing Legal Registration Holder vs. Contract Manufacturing Acceptable International Reports vs. Mandated Local Testing Find out who from CFDA will be attending this event . This event is brought to you through a collaborative effort from the RAPS Boston chapter and the ASQ New England Discussion Group of the Biomedical Division , and is intended to encourage knowledge sharing and community development among regulatory and quality professionals in the New England region. A full dinner buffet will be provided for all attendees. Attendees can claim four RAC recertification credits . Featured speaker: Grace Fu Palma, MBA , CEO, China Med Device Registration information: Prior to 17 October: RAPS and ASQ Members*: $85 Nonmembers: $105 On or after 17 October: RAPS and ASQ Members*: $100 Nonmembers: $120 *ASQ member contact your leadership team for a discount code. #BostonChapter

  • DC/Baltimore Chapter: Where is Industry Getting it Wrong? Surprising Reasons for Clinical Holds

    Oct 30, 5:30 PM - 8:30 PM
    Tuesday, 30 October 2018 George Washington University School of Medicine and Health Sciences 2100 Pennsylvania Avenue Washington, DC 20007 +1 202 994 2987 According to the Pink Sheet, IND clinical holds by the US FDA have risen 36% since 2014. These holds cause major concerns for patients that an IND represents a glimmer of hope. Companies hoping to speed their drug candidate to market fear the impact that a clinical hold might have on their bottom line. We invite you to come participate in an interactive session that will cover the many reasons for clinical holds and a deep dive into appropriate steps to take to avoid them. Join colleagues from the local regulatory community for an evening of networking and learn how to avoid the pitfall of a clinical hold. This event is sponsored by the RAPS DC/Baltimore chapter and is intended to promote knowledge sharing and engagement between regulatory and related professionals in our region. Attendees should arrive by 5:45 pm to participate in a drawing for special giveaways. Dinner will be provided and RAC holders may claim two RAC recertification credits . Featured speaker: Daniela Drago, RAC, PhD , director regulatory affairs programs at GW's School of Medicine and Health Sciences Registration information: Prior to 19 October: *Student: $20 Member: $30 Nonmember: $40 On or after 19 October: *Student: $25 Member: $40 Nonmember: $50 Contact RAPS Customer Service to register at the student registration rate (+1 301 770 2920 ext. 200).

  • The Impact of the EU MDR Regulation on Legacy Devices

    Nov 7, 9:00 AM - 3:00 PM
    The EU MDR significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the MDD. Legacy devices can no longer be “grandfathered” into compliance and the implications are significant, from updating technical documentation, to changing product labels, and demonstrating robust clinical evidence. Manufacturers must start considering their transition plan for applying these new requirements to keep their devices in the EU market. This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding the of the impact of the changes on legacy products and will enable attendees to leave the workshop with a clearer path for creating the transition plan. NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. Program Schedule Wednesday, 7 November (09:00 – 16:30) Topics will include (but not limited to): Interpreting the transition timelines No grandfathering means more conformity assessments Impact on OBL manufacturers CMR substances Classification changes on legacy devices Certification renewals for legacy devices Challenges with notified body designation Thursday, 8 November (09:00 - 15:00) Labeling changes for legacy devices – new requirements, symbols, UDI Use of ISO vs EN standards Planning for continuous PMS and PMCF CER requirements SSCP uploads to Eudamed Updating the technical documentation In group activities, attendees will work with: Considerations for product termination vs continuation Priority setting Portfolio revision Budgeting resources NOTE: The agenda may vary based on changing requirements. Faculty Gert Bos, executive director, Qserve Lena Cordie, president, Qualitas Professional Services, LLC All requests for cancellation must be received in writing or by calling customer service by 8 October . Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Location Park Plaza Victoria Amsterdam, Damrak 1-5, 1012 LG Amsterdam, Netherlands Tel: +31 20 623 4255 Located in the center of Amsterdam, the Park Plaza Victoria hotel is your ideal starring point for both business and leisure travellers. A clever combination of antique and modern, Park Plaza Victoria Amsterdam boasts historic architecture and contemporary accommodation in the city centre, just a five-minute walk from Amsterdam Central Station. Check in to a room in our eye-catching building constructed in the 1890s. Hotel amenities include free Wi-Fi, flavourful on-site dining, a fitness centre, an indoor pool, a sauna and a solarium. Accommodation RAPS has negotiated a dedicated room allotment directly at the Park Plaza Victoria Amsterdam hotel for workshop participants. To benefit from these special rates, delegates are encouraged to book directly by using the hotel hyperlink above . Reservations made directly online via the hotel website or any alternative booking service sites will unfortunately not benefit from preferential rates. Cancellation All requests for cancellation must be received in writing or by calling customer service by 8 October . Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 24 October . Proof of Attendance RAPS will send an electronic letter or a certificate of attendance upon request. Questions Call RAPS Solutions Center at +1 301.770.2920, Ext 200 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Registration Form If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, Ext 291 #EuropeEvents

  • Sponsored Webcast: Designing Clinical Trials for Success without Breaking the Bank

    Nov 7, 12:00 PM - 1:30 PM
    7 November 2018 12:00 – 1:30 pm EST This webcast will describe the process of designing clinical studies, covering initial questions that can guide development of a study framework and transitioning into discussion of a multitude of factors that must be evaluated in the design process (e.g., purpose, regulatory pathways, patient population, endpoints, and hypotheses.) You will also hear about additional considerations that can be cost drivers (e.g., monitoring, various oversight committees, etc.) Learning Level Basic : Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities. Learning Objectives Upon the webcast's conclusion, you will be able to: understand the factors that drive successful study design approach clinical study design with an initial understanding of when to incorporate these elements offer alternatives to study design when conflicts arise between cost, speed and scientific rigor Who should attend? Regulatory scientists Clinical scientists R&D personnel Speakers William D. Voorhees III, vice president/chief science officer, MED Institute William D. Voorhees, PhD, is the vice president & chief science officer at MED Institute. He joined the Clinical Trials/New Product Approvals Group at MED Institute in 1990. Voorhees’ commitment to patients is to ensure the quality and integrity of MED Institute’s research, as well as of submissions to regulatory authorities and manuscripts to disseminate information about this research. He earned his PhD in Veterinary Physiology & Pharmacology from Purdue University and has authored over 70 referenced articles. Theodore Heise, vice president, regulatory and clinical services, MED Institute Theodore Heise, PhD, has 25 years of experience in regulatory affairs and currently serves as vice president of regulatory and clinical services for MED Institute. In this capacity, he has responsibility for the scientific aspects of the company’s global regulatory affairs efforts, including design and analysis of clinical studies of new technologies. Heise is a U.S. delegate to the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices and serves as convener of its working group on chemical characterization. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.

  • Chicago Chapter: EU MDR Updates – Annex II Technical File Documentation

    Nov 8, 5:15 PM - 8:45 PM
    Thursday, 8 November 2018 5:15–8:45 pm CDT Hollister Inc. 2000 Hollister Drive Libertyville, IL 60048 +1 800 323 4060 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come engage with professionals from your local regulatory community for an interactive session on how to prepare for the implementation and learn strategies to help your device company navigate the higher level of scrutiny, including: Annex II Technical File Documentation. (EU MDR 2017/745 ANNEX II TECHNICAL DOCUMENTATION: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include the elements listed in this Annex.) Classification rules of MDR Technical documentation assessment process How to ensure a smooth transition to MDR certification Latest updates on EU MDR This program, hosted by Hollister Inc. , is brought to you by the RAPS Chicago chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits . Featured speaker: Caroline Dore Geraghty , head of medical devices, NSAI (National Standard Authority in Ireland) Registration Information: RAPS Members: $30 Nonmembers: $45

  • Texas Chapter: Applying Human Factors Engineering to support FDA and CE Mark Submissions

    Nov 9, 6:00 PM - 8:00 PM
    Friday, 9 November 2018 6:00-8:00 pm CDT Emergo by UL Headquarters 2500 Bee Cave Road Building One, Conference Room B120 Austin, TX 78746 +1 512 327 9997 Come engage with professionals from your local regulatory community for an interactive presentation on the important role that human factors engineering plays in the submission of medical devices. FDA’s human factors engineering (HFE) guidance, issued in its final form in February 2016, as well as IEC 62366-1:2015, describe substantial expectations for how medical device developers should apply HFE. These high expectations apply to new products and, in some cases, existing (i.e., legacy) devices. During this talk, UL’s Andrea Dwyer, managing human factors specialist and co-author of the book Medical Device Use Error – Root Cause Analysis , will provide a general introduction to HFE practices aligned with today’s regulatory landscape. The presentation will include tips on effective strategies to fulfill both FDA’s expectations and those established by the IEC standard, which is upheld by many other regulators. Following this presentation, we will have an interactive question and answer period. This event is coordinated by the RAPS Texas chapter and is intended to encourage knowledge sharing and community development among local regulatory professionals. A light meal will be provided and RAC holders may claim two RAC recertification credits . Featured speaker: Andrea Dwyer, MS, CHFP , managing human factors specialist, UL-Wiklund Registration Information: RAPS Members: $25 Nonmembers: $40

  • RAPS Utah Chapter: Peer-Led US RAC Study Group

    Nov 12, 5:30 PM - 8:00 PM
    Monday, 12 November 2018 5:30-8:00 pm MST MasterControl-Cottonwood Heights Facility 6350 South 3000 East Building Old Mill III Salt Lake City, UT 84121 +1 800 942 4000 Are you planning to take the US Regulatory Affairs Certification (RAC) exam ? Want a jump start on studying for the spring 2019 exam? Interested in learning more about the regulatory environment in the U.S.? If so, the RAPS Utah Chapter invites you to join others for an informal peer-led RAC Study Group to help prepare. This session will include peer-led discussions that will help you prepare for the exam and get the extra knowledge you are looking for. Hosted by MasterControl at their Cottonwood Heights facility , we will cover test taking tips and collectively discuss the domains included on the exam. We’ll also explore sample exam questions and will dive into test taking tips and best practices. It is highly recommended that attendees possess a minimum of two to three years regulatory experience, as the session will be geared towards those that have at least a basic understanding of the regulatory profession. The primary resource used during each session will be RAPS' flagship study tool, Fundamentals of US Regulatory Affairs, 10th edition . Beverages will be provided by MasterControl, but we encourage you to bring a snack or brown bag dinner. This activity is provided by the RAPS Utah chapter and is intended to encourage engagement and professional development for those is the local regulatory community. This first chapter activity is free to attend, but advance registration is necessary, so we hope to see there. Registration Information: RAPS Members: Free Nonmembers: Free

  • Introduction to Electronic Regulatory Submissions in the eCTD Format-November 2018

    Nov 13, 9:00 AM - 3:00 PM
    Introduction to Electronic Regulatory Submissions in the eCTD Format-November 2018 13 November 2018 (9:00 am–4:00 pm PST) 14 November 2018 (9:00 am–3:00 pm PST) New Horizons Learning Center San Diego, CA 92126 Do you need to comply with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: Different submission types Which applications need to be submitted electronically How to understand and follow the CTD structure How to use the M4 series of guidances and granularity to generate compliant submissions Agency-compliant PDF files and how to generate them Which agency guidelines and technical specifications publishers need to follow What tools are required to electronically submit your applications Join us for this two-day, training that will answer your eCTD questions and help you get on a direct path to compliance. Program Dates : 13-14 November 2018 Meeting Location: New Horizons Learning Center 7480 Miramar Drive San Diego, CA 92126 Registration Closes : 6 November 2018 Refund Deadline : 14 October 2018 RAC Credits : 8 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 15 October 2018 RAPS Members: $1,250 Nonmembers: $1,350 Registration from 16 October 2018 RAPS Members: $1,350 Nonmembers: $1,450 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives After this program, participants will be able to: Understand the acronyms and terms surrounding electronic submissions Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD Identify best practices with software used to generate electronic submission content Produce MS Word and PDF documents that meet FDA guidelines Obtain a basic understanding of what is required to transition into submitting in the eCTD format Who Should Attend The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the fast-approaching FDA electronic submission deadlines for eCTD in May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation. Agenda Define important terminology used in e-submissions Provide a detailed breakdown of the CTD structure Understand the M4 guidances (ICH) and FDA Technical Specifications Learn how to create FDA-compliant MS Word documents Learn how to create FDA-compliant PDF documents from differing sources Review the workflow process using planners to produce an eCTD Learn how to convert from a paper application to an eCTD application Learn the basics of managing an electronic submissions project Review the entire Lifecycle of an electronic submission from first steps to eCTD Learn tips, tricks and best practices What does eCTD readiness mean? NOTE: Program content may vary. Faculty Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Registration Info NOTE: The training facility will provide each student with computers for this program. Registration to 15 October 2018 RAPS Members: $1,250 Nonmembers: $1,350 Registration from 16 June 2018 RAPS Members: $1,450 Nonmembers: $1,550 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 14 October 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Parking Ample parking is available at the training center. Area Airports San Diego International Airport (18 miles) Area Hotels The following hotels are located near the New Horizons Training Center. San Diego Marriott La Jolla La Jolla, California 92037 USA Reservations: 1-858-587-1414 4240 La Jolla Village Drive Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California, USA, 92122 Reservations: 1-858-552-1234 Holiday Inn Express & Suites San Diego-Sorrento Valley 5925 Lusk Blvd. San Diego, California 92121 USA Reservations: 1-858-731-0100 Cancellation All cancellation requests must be submitted to raps@raps.org by 14 October 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 30 October 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Wisconsin Chapter: Medical Device Risk Management

    Nov 13, 5:30 PM - 8:30 PM
    Tuesday, 13 November 2018 BioPharmaceutical Technology Center 5445 East Cheryl Parkway Fitchburg, WI 53711 +1 608 277 2669 For medical devices, risk management spans the entire product lifecycle, from development to deployment and decommissioning. It is an essential system to ensure expectations for product safety on the drawing board are realized in actual clinical use. More and more quality systems and product standards rely on risk management to set priorities and make decisions, out of less than complete information. Join others from your region to hear two interactive presentations on managing risk throughout the product lifecycle. The first presentation will outline how closed-loop risk management can support consistent decision making for safety throughout the product lifecycle for any medical device. The second presentation will discuss risk management considerations specific to In Vitro Diagnostic (IVD) medical devices, such as how to consider harm for devices that do not directly contact patients. It will also explore risks in the context of how a device is used, which may require the device to work in combination with other reagents, instruments and/or software to provide a reliable result. Don’t miss this unique opportunity to learn new and innovative ways to manage risks while connecting with others from your local regulatory community. This event, hosted at Promega Corporation , is coordinated by the RAPS Wisconsin chapter and is intended to encourage professional development and engagement among regulatory professionals in your areas. A meal will be available for all participants and RAC holders may claim three RAC recertification credits . Featured speakers: Daniel Biank, RAC, JD, MSE, PE , vice president, regulatory affairs, global EHS and radiation safety, Accuray Carol Lindsay, RAC, PhD , senior scientist, Promega Corporation Registration Information: RAPS Member: $30.00 Nonmember: $45.00

  • Intermediate Course for Regulatory Submissions in eCTD Format–November 2018

    Nov 15, 9:00 AM - 3:00 PM
    Intermediate Course for Regulatory Submissions in eCTD Format 15 November (9:00 am–4:00 pm PST) 16 November (9:00 am–3:00 pm PST) New Horizons Learning Center San Diego, CA 92126 If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements, this course is for you. Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: How to comply with the May 2018 electronic submissions requirements Which agency guidelines and technical specifications publishers need to follow How to apply ICH and regional requirements to your eCTD How to compile documents into the XML backbone of an eCTD, and lifecycle that application How to QC and validate an eCTD How metadata and study tagging files work Tips, tricks and best practices gathered from industry professionals How convert from a paper application to an eCTD How the new Module 1 (version 3.3) can be used for regulatory submissions What CTD readiness really We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ. Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance. Program Dates : 15-16 November 2018 Meeting Location: New Horizons Learning Center 7480 Miramar Road #202 San Diego, CA 92126 Registration Closes : 8 November 2018 Refund Deadline : 16 October 2018 RAC Credits : 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Registration Fees: Registration to 15 November 2018 RAPS Members: $1,350 Nonmembers: $1,450 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. Objectives At the conclusion of this program, participants will be able to: Identify best practices with software used to generate electronic submission content Understand the acronyms and terms surrounding eCTD and electronic submissions Apply ICH and regional requirements for the content of an eCTD submission Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA. Obtain an understanding of what is required to transition into submitting in the eCTD format. Who Should Attend This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. Agenda How to comply with the May 2018 electronic submission requirements Guidances that govern electronic submissions How to electronically submit to FDA Generating compliant PDF files—best practices in MS Word and Adobe Acrobat Hands-on compilation of an eCTD Module 1 differences between US and Rest of World Creating the initial sequence of an application Assigning the metadata required by the regional authority and ICH Lifecycling the application Publishing and validating the application Compiling will include: Study Tagging Files (STFs) Datasets SPLs (Structured Product Labeling) Granulated Clinical Study Reports (gCSR) Challenges with preparing compliant eCTD submissions Review and QC of the compiled application Common and avoidable errors that could get your submission rejected Tips, tricks and best practices gathered from industry professionals Converting from a paper application to an eCTD application What eCTD readiness really means NOTE: Program content may vary. NOTE: The training facility will provide each student with computers for this program. Faculty Elsmari Eggers , head of training and RA consulting, LORENZ Life Sciences Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Jared Lantzy , PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Registration Info IMPORTANT: The training facility will provide each student with computers for this program. Attendees may bring their own laptops, but all exercises will take place on the computers supplied by the training center. Registration to 8 November 2018 RAPS Members: $1,450 Nonmembers: $1,550 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 13 March 2018 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Area Airports San Diego International Airport (18 miles) Area Hotels The following hotels are located near the New Horizons Training Center. San Diego Marriott La Jolla 4240 La Jolla Village Drive La Jolla, California 92037 USA Reservations: 1-858-587-1414 Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California, USA, 92122 Reservations: 1-858-552-1234 Holiday Inn Express & Suites San Diego-Sorrento Valley 5925 Lusk Blvd. San Diego, California 92121 USA Reservations: 1-858-731-0100 Cancellation All cancellation requests must be submitted to raps@raps.org by 16 October 2018 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 1 November 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org . NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • The Basics of 510K

    Nov 15, 9:00 AM - 3:00 PM
    Most medical devices in the US today are marketed under the premarket notification (510(k) authorities of the Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of the regulatory fundamentals; practical guidance on how to develop, prepare and submit a 510(k) to FDA; and how to engage with FDA. Program Dates : 15 November 2018 (9:00 am – 4:00 pm) 16 November 2018 (9:00 am – 3:00 pm) Meeting Location : New York New York Hotel 3790 Las Vegas S Boulevard Las Vegas, Nevada 89109 Registration Closes : 8 November 2018 Refund Deadline : 16 October 2018 RAC Credits : 10 RAC recertification credits upon completion of the program Will this meeting be recorded ? No Proof of Attendance : An electronic letter of attendance will be sent upon request. Registration Fees : Registration until 16 October 2018 RAPS Members: $1,050 Nonmembers: $1,150 Registration from 17 October 2018 to 8 November 2018 Members: $1,150 Nonmembers: $1,250 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited so register early for this program.   Objectives : After this program, participants will be able to: • Describe the regulatory framework and introduction to 510(K) • Develop the underlying data and documentation needed to support a 510(k) submission • Prepare a 510(k) submission with all required sections through the submission phase. • Interact confidently with FDA during the 510(k) review process including what to do if things go wrong. Who Should Attend This program would be appropriate for individuals who have never submitted a 510(k) and those who have some experience and are looking to sharpen their skills. Agenda • FDA Medical device regulatory framework and introduction to 510(k) • Developing a regulatory strategy • Developing underlying documentation, including biocompatibility, sterilization, software, electrical and EMC testing, bench testing • Preparing your 510(k) submission • Interacting with FDA during the 510(k) review process • Device changes after clearance NOTE : Program content may vary. Faculty Tony Blank , President, Infinity Biomedical Group, LLC Donna-Bea Tillman , Ph.D., FRAPS, Team Leader and Senior Consultant, Medical Devices, Biologics Consulting Registration Info Attendees must bring their own laptops. RAPS does not provide equipment for attendees. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. If you or your company will mail a check for payment, please include a completed registration form for the participant. Questions ? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline : 16 October 2018   Other Information : RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Hotel Accommodation RAPS has secured a limited number of discounted rooms at the New York New York Hotel for workshop attendees. To receive the discounted rate, bookings must be made using the following link https://book.passkey.com/e/4975361 by 23 October . The room rate is $99.00 per night + $37.00 per day resort fee, plus all applicable room taxes. Rate includes complimentary breakfast buffet and free WiFi Internet for all in-house guests. Transportation Driving Directions Parking Taxi Cancellation All cancellation requests must be submitted to raps@raps.org by 16 October 201 8. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org by 1 November 2018 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE : RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • New York/New Jersey Chapter: Pay Now or Pay Later – the Impact of Human Factors on Regulatory Submis

    Nov 15, 5:30 PM - 8:30 PM
    Thursday, 15 November 2018 5:30-8:30 pm EDT Porzio, Bromberg & Newman, PC 100 Southgate Parkway Morristown, NJ 07962-1997 +1 973 538 1690 There have been significant changes in both the US and global regulatory environments affecting human factors for medical devices and combination products. While done with good intent, many of these changes have added complexity and, in some cases, confusion about how to ensure a successful human factors submission. On top of that, many may not be aware that human factors are required in most cases, and you can see why this is such an important topic. Join others from your local regulatory community to gain a better understanding of: How human factors studies are conducted How they differ from clinical studies What are the most common issues that can derail a human factors submission. During this interactive session, attendees will watch an excerpt of a human factors study to highlight the qualitative aspects of this type of research study and why it takes so long to conduct. The case study (representing both device and combination product perspectives) will showcase regulatory strategies and the purposes of the human factors study (formative/validation). It will also help participants better understand the impact that the study results have on the submission and why the impact occurred. Learning Objectives: Understand how human factors requirements fit into the overall product development and regulatory submission schedule. Understand how changing regulatory strategies can impact the human factors strategy. Identify key differences between clinical studies and human factors studies. Explore common myths associated with human factors. The engagement activity is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Light refreshments will be available to all attendees and RAC holders may claim two RAC recertification credits . Featured speaker: Renee Bailey , Agilis Consulting Group, LLC Registration Information: Prior to 8 November 2018 RAPS Members: $35 Nonmember: $50 On or after 8 November 2018 RAPS Members: $45 Nonmembers : $60

  • Twin Cities Chapter: Smorgasbord Session – Multiple Topics and Multiple Speakers

    Nov 29, 5:30 PM - 8:30 PM
    Thursday, 29 November 2018 5:30-8:30 pm CST Minnesota Landscape Arboretum Fireplace Room and Balcony 3675 Arboretum Drive Chaska, MN 55318 +1 952 443 1400 2018 has been quite the year for regulatory news and change. So much has happened that it’s difficult to keep up with everything. To help make sure you’re up to speed on all the changes in the regulatory profession, the RAPS Twin Cities chapter invites you to join us on 29 November for a “smorgasbord” event. During this interactive session, you will hear several brief presentations from your fellow chapter members. Registrants will also have full-day access (8:00 am-8:30 pm) to the grounds of the Minnesota Landscape Arboretum , so you can enjoy the beauty of the fall foliage before the event. Scheduled topics include: ISO 13485 & Harmonization efforts Post-market Surveillance Symbols, Labeling & UDI RAPS 2018 Convergence Highlights IVDR Brexit Update Cybersecurity GDPR Reimbursement Mobile Medical Applications MDR Implementing Acts The program will include 10-15 minute presentations covering the above topics and will include a designated time to engage with colleagues to help grow your network moving into 2019. This activity is brought to you by the RAPS Twin Cities chapter and is intended to facilitate professional development and networking for regulatory professionals in your region. Heavy appetizers will be provided for all attendees and RAC holders may claim three RAC recertification credits . Registration Information: Student: $30* Member: $45 Nonmember: $60 Local contact: Lena Cordie , chair, RAPS Twin Cities Chapter *Contact RAPS Customer Service (+1 301 770 2920 ext. 200) To register at the student rate.

  • The Impact of the EU MDR Regulation on Legacy Devices - Minneapolis

    Dec 4, 9:00 AM - 5:00 PM
    The EU MDR significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the MDD. Legacy devices can no longer be “grandfathered” into compliance and the implications are significant, from updating technical documentation, to changing product labels, and demonstrating robust clinical evidence. Manufacturers must start considering their transition plan for applying these new requirements to keep their devices in the EU market. This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding the of the impact of the changes on legacy products and will enable attendees to leave the workshop with a clearer path for creating the transition plan. Registration Closes : 27 November 2018 Refund Deadline : 4 November 2018 RAC Credits: 12 (Upon attending and completing the program) Will the meeting be recorded? No Registration to 4 November 2018 RAPS Members: $850 Nonmembers: $950 Registration from 5 November to 27 November 2018 RAPS Members: $950 Nonmembers: $1050 NOTE : Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. Program Schedule Tuesday, 4 December (9:00am–5:00pm) Topics will include (but not limited to): Interpreting the transition timelines • No grandfathering means more conformity assessments • Impact on OBL manufacturers CMR substances • Classification changes on legacy devices • Certification renewals for legacy devices • Challenges with notified body designation Wednesday, 5 December (9:00am-5:00pm) Labeling changes for legacy devices – new requirements and symbols • Use of ISO vs EN standards • Planning for continuous PMS and PMCF • CER requirements • SSCP uploads to Eudamed • Updating the technical documentation In group activities, attendees will work with: • Considerations for product termination vs continuation • Priority setting • Portfolio revision • Budgeting resources NOTE: The agenda may vary based on changing requirements. Faculty Lena Cordie, president, Qualitas Professional Services, LLC Gert Bos, executive director, Qserve All requests for cancellation must be received in writing or by calling customer service by 4 November . Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Location University of St. Thomas 1000 LaSalle Avenue, Schulze Hall, Room #421 Minneapolis, Minnesota 55403-2003 The University of St. Thomas Conference & Event Center will host the RAPS Legacy Products workshop in its state-of-the-art, technologically advanced event space. Accommodation Options Below is a list of nearby hotel properties near the University of St. Thomas. Minneapolis Marriott City Center (located 3 blocks away, available via indoor skyway) 30 South 7th Street Minneapolis, MN 55402 612-349-4094 Embassy Suites Downtown Minneapolis (located 6 blocks away) 12 South 6th Street Minneapolis, MN 55402 612-334 0619 DoubleTree Suites by Hilton (located across the street) 1101 LaSalle Avenue Minneapolis, MN 612-332-6800 Hampton Inn & Suites Minneapolis Downtown (located 3 blocks from campus available via indoor skyway) 19 North 8th Street Minneapolis, MN 55403 612-341-3333 Cancellation All requests for cancellation must be received in writing or by calling customer service by 4 November . Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 20 November . Proof of Attendance RAPS will send an electronic letter or a certificate of attendance upon request. Questions Call RAPS Solutions Center at +1 301.770.2920, Ext 200 Other Information RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Registration Form If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, Ext 291

  • Florida Chapter: Holiday Meet Up

    Dec 5, 5:00 PM - 8:00 PM
    5 December 2018 5:00–8:00 pm EST Bar Louie—International Plaza 2223 North Westshore Blvd #202 Tampa, FL 33607 +1 813 874 1919 Join your regulatory colleagues from the central Florida area for an informal meet-up to celebrate the holidays. This is a great opportunity to meet other regulatory professionals from your region in a fun and relaxed atmosphere. Leaders from the Florida Chapter will be onsite to talk about 2019 local activities, so you can plan your calendar accordingly. This event is coordinated by the RAPS Florida Chapter and is intended to encourage engagement and relationship-building in the local regulatory community. During this event, we'll hold a raffle for a complimentary e-book version of RAPS' flagship publication Fundamentals of Regulatory Affairs , valued at $395. You must be present to win. We hope to see you there. Light refreshments will be provided. Drink expenses will be the responsibility of each attendee. Registration Information: RAPS Members: Free (But registration is still required) Nonmember: $10

  • RAPS Wisconsin Chapter: Chapter Meet Up

    Dec 5, 5:30 PM - 8:00 PM
    Wednesday, 5 December 2018 5:30-8:00 pm CST Delafield Brewhaus 3832 Hillside Drive Delafield, WI 53018 +1 262 646 7821 Join colleagues from your local regulatory community for a networking “Meet-Up” and to hear highlights from the 2018 RAPS Regulatory Convergence in Vancouver. Attendees from this year’s Convergence will share what they learned from many of the educational sessions and keynote speakers. This is a great opportunity to learn from industry colleagues while meeting other regulatory professionals from your region in a fun and relaxed atmosphere. Bring your ideas for potential 2019 activities and learn about volunteer opportunities within the chapter! This event is coordinated by the RAPS Wisconsin chapter and is intended to promote and facilitate connections among local regulatory professionals. Light refreshments will be available for all. Drink expenses will be the responsibility of each attendee. Registration Information: RAPS Member: $5.00 Nonmember: $10.00

  • Atlanta Chapter: Annual Breakfast with Atlanta FDA District Officers

    Dec 6, 7:30 AM - 10:30 AM
    Thursday, 6 December 2018 7:30-10:30 am EST Arnall Golden Gregory LLP 191 17th Street, NW Suite #2100 Atlanta It’s that time of year again! The time when representatives from the Atlanta District Food and Drug Administration (FDA) engage directly with regulatory professionals from the Atlanta metropolitan area. FDA representatives will present on the latest compliance and enforcement related topics and will take questions from the audience. The primary topics covered during these presentations will include: Atlanta district office reorganization Update on district compliance and inspection results Recall actions and tips from FDA This annual event, hosted by Arnall Golden Gregory LLP , is coordinated by the RAPS Atlanta Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Don’t miss this unique opportunity to get your questions answered directly by the Atlanta District FDA. A light breakfast will be provided and RAC holders may claim three  RAC recertification credits .    Featured speakers: Ingrid Zambrana, Atlanta FDA district office director/OHAFO E3 program division director LaReese Thomas , supervisor, Consumer Safety Office, Atlanta FDA District Office Registration Information: Prior to 29 November RAPS Members:  $30 Nonmembers:  $45 On or After 29 November RAPS Members:  $40 Nonmembers:  $55 #AtlantaChapter

  • Virtual Program: Key Challenges in Preparing for EU Medical Device Regulation (MDR)

    Dec 6, 11:00 AM - 4:00 PM
    6 December 2018 11:00 – 4:15 pm EST Registration Information Register by 28 Nov RAPS Members: $ 399 Nonmembers: $ 460 Register after 28 Nov RAPS Members: $ 499 Nonmembers: $ 575 The new European Medical Devices Regulation (MDR) was published in May 2017 to improve the safety and efficacy of medical devices in the EU. This regulation replaces two of the existing medical device directives by 2020. The transition window for compliance with MDR is rapidly closing, manufacturers need to be making urgent progress in addressing changed requirements and generating supporting evidence needed to for both new and existing legacy CE Marked AIMD/MDD devices. Regulatory affairs professionals with responsibility for European devices can’t afford to wait until all the supporting guidance documents and expectations are fully clarified, it is important to make assessments now to anticipate how to address new requirements while there is still enough time to generate the information, balancing how much is expected to be enough with the expense of doing too much. This program will be focusing on key areas requiring significant effort to evaluate and update to maintain access to the European marking such as understanding clinical data expectations, generating clinical evaluation reports, updating technical documentation and preparing for enhanced post-market requirements. Learning Objectives: Understand the impact of the new clinical requirements on clinical evidence Understand new expectations of clinical evaluation reports Understand the technical documentation required to demonstrate compliance Understand enhanced post-market expectations Who Should Attend: Medical device regulatory affairs staff responsible for compliance, submissions, clinical and post market of products intended for Europe Consultants and suppliers supporting medical device regulatory affairs staff Learning Levels: Basic, Intermediate Speakers: Mindy McCann, vice president of regulatory compliance, Qserve Group Keith Morel, vice president of regulatory compliance, Qserve Group Additional Speakers TBA

  • Vancouver Chapter: Human Factors Simplified

    Dec 6, 5:30 PM - 8:00 PM
    Thursday, 6 December 2018 5:30-8:00 pm PST LifeScan Canada 210-4321 Still Creek Drive Burnaby, BC V5C 6S7 +1 604 293 2266 In recent years, US and global regulatory agencies have placed greater emphasis on human factors requirements for medical devices and combination products. The FDA’s Human Factors Engineering guidance and IEC 62366-1:2015 detail the process manufacturers must follow. However, due to great diversity in the devices being created, many struggle to understand how the regulations should be applied to their specific devices. This interactive presentation will help simplify the human factors process by breaking it down into three main activities: identification, formative research and validation testing. Topics to be discussed include: how human factors fits into product development and design controls description of the costs associated with human factors studies strategies for identifying device users, use environments and critical tasks methodological differences between formative, validation and summative studies how to write up positive and negative results from human factors studies The engagement activity is brought to you by the RAPS Vancouver chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Dinner will be available to all attendees and RAC holders may claim two RAC recertification credits . Featured speaker: Bryant Foster, MS , vice president, human factors and user experience, Research Collective Registration Information: RAPS Member: $25 Nonmember: $40

  • Webcast: Risk Evaluation and Mitigation Strategies: Modifications and Revisions – Guidance for Indus

    Dec 11, 12:00 PM - 1:00 PM
    11 December 2018 12:00 – 1:00 pm EST The Food & Drug Administration Safety and Innovation Act (FDASIA) of 2012 amended the Risk Evaluation and Mitigation Strategies (REMS) modification provisions. FDASIA identified different types of REMS changes and directed FDA to issue guidance. FDA issued the Risk Evaluation and Mitigation Strategies: Modification and Revision - Guidance for Industry in April 2015. This webcast will provide an overview of the REMS: Modification and Revision Guidance. You will learn about the different types of REMS changes and how to submit the different types of REMS changes to FDA. You will also learn about FDA’s process for reviewing and acting on different types of REMS changes. Learning Level Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Understand the different categories of REMS changes in the draft guidance Understand the application holder submission procedures for the different types of REMS changes Understand FDA’s proposed process for reviewing and acting on different types of REMS changes Who should attend? Professionals involved in: Risk Evaluation and Mitigation Strategies (REMS) Regulatory Affairs Risk Management Speaker Brian Gordon, MA, regulatory health policy analyst, Food and Drug Administration Brian Gordon is a regulatory health policy analyst in the Division of Risk Management (DRISK) in FDA’s Office of Medication Error Prevention and Risk Management within the Office of Surveillance and Epidemiology (OSE). He has been with the FDA since 2008. He works on developing and implementing policies and processes related to REMS.

  • Twin Cities Chapter: Chapter Networking and Holiday Social

    Dec 17, 5:00 PM - 8:00 PM
    Monday, 17 December 2018 5:00–8:00 pm CST Champps – Minnetonka 1641 Plymouth Road Minnetonka, MN 55305 +1 952 546 3333 Join regulatory colleagues from your area for an informal meet-up to celebrate the holidays. This is a great opportunity to meet other regulatory professionals from your region in a fun and relaxed atmosphere. Leaders from the Twin Cities Chapter will be onsite to talk about 2019 activities, so you can plan your calendar accordingly. We'll hold a raffle for a complimentary e-book version of RAPS' flagship publication Fundamentals of Regulatory Affairs , valued at $395. You must be present to win. We hope to see you there. Light refreshments will be provided, and drink expenses will be the responsibility of each attendee. We also invite you to participate in the “RAPS Twin Cities Chapter Gives Back” holiday initiative. We’ll be collecting donations for Ready for Success , a non-profit organization that provides low-income women and men with gently-used and new professional clothing, accessories and new personal care items suitable for job interviews and the workplace. To participate, consider bringing new or gently used accessories (i.e. scarves, jewelry, ties, belts or new socks) with you to the Holiday Social. Registration Information: Student: Free Member: Free Nonmember: $10 #TwinCitiesChapter

  • New York/New Jersey and Philadelphia Chapter: RA/QA Career and Networking Event

    Jan 15, 4:00 PM - 8:00 PM
    Tuesday, 15 January 2019 4:00–8:00 pm EST Temple University Fort Washington Campus 425 Commerce Drive Fort Washington, PA 19034 +1 267 468 8500 Join regulatory, quality and compliance colleagues from your region to learn about the profession and engage directly with hiring representatives looking to recruit regulatory talent. Invited speakers include FDA representatives, veteran regulatory professionals, academia and others. This interactive event is designed to help you get started or advance your career in the regulatory field. The panel of speakers will cover a diverse range of topics including; transitioning to a career in regulatory the Benefits of Regulatory Affairs Certification (RAC) other education and professional development opportunities for regulatory careers resume writing This event is coordinated through a partnership between the RAPS New York/New Jersey and Philadelphia Chapters , along with the Temple University, School of Pharmacy, RA/QA Graduate Program and is intended to facilitate networking and knowledge sharing among regulatory professionals in the region. Light refreshments will be available for all attendees and RAC holders may claim four RAC recertification credits . Temple students should contact RA/QA program staff for registration instructions. Registration Information: RAPS Member: $20 Nonmember: $30 #NY/NJChapter #PhiladelphiaChapter #SanFranciscoChapter #TexasChapter

  • Chicago Chapter: Requesting Feedback - FDA’s Presubmission Process

    Jan 24, 5:30 PM - 8:30 PM
    Thursday, 24 January 2019 5:30-8:30 pm CST AbbVie One 26525 North Riverwoods Road First Floor, São Paulo Conference Room Mettawa, IL 60045-3440 +1 800 255 5162 Join local regulatory professionals for a presentation on the Food and Drug Administration’s (FDA) Presubmission Process. The mechanisms applicants can use to request feedback from FDA about potential or planned medical device Investigational Device Exemption (IDE) applications or other premarket submissions, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) will be reviewed. The logistics for submission, receipt, tracking and review of/response to these requests also will be discussed. In addition, there will be information on feedback mechanisms, including Pre-Submissions, Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings (i.e., Agreement and Determination Meetings), Submission Issue Meetings and PMA Day 100 Meetings. These feedback requests are collectively referred to as “Q-Submissions” or “Q-Subs.” FDA believes the Q-Sub structure provides a convenient and effective way to track them. This program is brought to you by the RAPS Chicago chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits . Featured Speaker: Deborah Baker-Janis, RAC, MS , senior director, NSF Medical Devices Registration Information: RAPS Members: $30 Nonmembers: $45 #ChicagoChapter

  • Utah Chapter Kick-Off and Networking Event

    Jan 25, 5:00 PM - 8:00 PM
    Friday, 25 January 2019 5:00-8:00 pm MST Merit Medical 1600 West Merit Parkway South Jordan, UT 84095 +1 801 253 1600 Join others from your local regulatory community for the official kick-off of the RAPS Utah Chapter . Engage with volunteer leaders of the chapter to hear about upcoming activities and find out how you can get involved. We expect attendees from a wide range of backgrounds including regulatory, quality, bioengineering and other related industries. This event represents a great opportunity to expand your professional network as we move into the new year. Our gracious host, Merit Medical , will provide hors d’oeuvres for all attendees and we hope to see you there. Registration Information: RAPS Member: Free Nonmember: $5.00 #UtahChapter

  • Sponsored Webcast: Lessons Learned: Implementing an End-to-End Regulatory Information Management (RI

    Jan 30, 12:00 PM - 1:00 PM
    30 January 2019 12:00 – 1:00 pm EST Implementing an end-to-end Regulatory Information Management (RIM) solution can have significant impacts on your short term and long-term regulatory processes. Join this webcast to hear IONIS’ Christie Hamel and United Therapeutics’ Hilary Hafeken describe their experiences with implementing a unified RIM solution. These presenters will cover process improvements and lessons learned in submission management, health authority interactions and reporting, followed by a Q&A session with the live audience. Learning Levels Basic : Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities. Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: · Identify which regulatory processes are most critical to a successful end-to-end implementation · Optimize submission planning, tracking and health authority interaction management · Leverage workflows to streamline regulated content management and improve quality · Utilize reports to increase transparency and visibility across the organization of key regulatory events and activities · Plan for an effective data and document migration Who should attend? Professionals involved in: Business and/or IT leads for regulatory systems Regulatory personnel responsible for coordinating with regional offices or local affiliates Anyone involved in implementing or expanding global systems Speakers Christie Hamel, director of regulatory operations, IONIS Pharmaceuticals Christie Hamel is the director of regulatory operations at Ionis Pharmaceuticals where she has lead the group for the past eight years. Prior to her time at Ionis, Hamel managed regulatory operations teams at Datafarm Inc. and PAREXEL. Over the years, she has enjoyed implementing new software, submission formats and processes. The company has embraced eCTD submissions, two different eCTD building software systems, word templates and Electronic Document Management System (EDMS) processes. Hilary Hafeken, director of regulatory informatics, United Therapeutics Hilary Hafeken is director of regulatory informatics at United Therapeutics. With over 15 years' experience in the pharmaceutical industry, she has successfully implemented four EDMS and three electronic publishing systems. Hafeken’s successes include leading the change from paper to electronic submissions and transitioning to a cloud-based solution. Ginny Smith, associate manager of regulatory informatics, United Therapeutics Ginny Smith has been a regulatory professional since 2002 and has over ten years’ experience working with electronic regulatory submissions. She has been at United Therapeutics for seven years. During her time with UT, she has worked on numerous Investigational New Drug (IND) and New Drug Application (NDA) submissions, spearheaded her group’s management of an original Marketing Authorization Application (MAA), Biologics License Application (BLA), and NDS. She has also contributed as a member of the teams implementing a new Document Management System, publishing tool and Regulatory Information Management system. Rachel Belani, director of Vault RIM, Veeva Rachel Belani has 14 years of experience in the pharmaceutical industry. She is currently a member of the global regulatory strategy team at Veeva. Before joining Veeva, Belani’s career was focused on developing solutions and processes for life sciences organizations, with a specific focus on regulatory, clinical and safety. She started off her career at Actelion Pharmaceuticals where she served as the Americas lead for R&D systems and processes, including ECM/EDMS, archiving, CTMS, LMS, ERP, analytics and reporting for clinical development. Following Actelion, Belani transitioned into a consulting role where she helped life science companies define and optimize their business and solution architecture, from both a clinical and regulatory perspective.

  • New York/New Jersey Chapter: Pay Now or Pay Later – the Impact of Human Factors on Regulatory Submis

    Jan 31, 5:30 PM - 8:30 PM
    Thursday, 31 January 2019 5:30-8:30 pm EDT Porzio, Bromberg & Newman, PC 100 Southgate Parkway Morristown, NJ 07962-1997 +1 973 538 1690 There have been significant changes in both the US and global regulatory environments affecting human factors for medical devices and combination products. While done with good intent, many of these changes have added complexity and, in some cases, confusion about how to ensure a successful human factors submission. On top of that, many may not be aware that human factors are required in most cases, and you can see why this is such an important topic. Join others from your local regulatory community to gain a better understanding of: How human factors studies are conducted How they differ from clinical studies What are the most common issues that can derail a human factors submission. During this interactive session, attendees will watch an excerpt of a human factors study to highlight the qualitative aspects of this type of research study and why it takes so long to conduct. The case study (representing both device and combination product perspectives) will showcase regulatory strategies and the purposes of the human factors study (formative/validation). It will also help participants better understand the impact that the study results have on the submission and why the impact occurred. Learning Objectives: Understand how human factors requirements fit into the overall product development and regulatory submission schedule. Understand how changing regulatory strategies can impact the human factors strategy. Identify key differences between clinical studies and human factors studies. Explore common myths associated with human factors. The engagement activity is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Light refreshments will be available to all attendees and RAC holders may claim two RAC recertification credits . Featured speaker: Renee Bailey , Agilis Consulting Group, LLC Registration Information: RAPS Members: $35 Nonmember: $50 #NY/NJChapter

  • Florida Chapter: Strategies to Navigate Changes to the EU MDR and Clinical Requirements

    Feb 1, 8:00 AM - 11:30 AM
    Friday, 1 February 2019 8:00- 11:30 am EST Jabil 888 Executive Center Dr West St. Petersburg, FL 33702 +1 727 577 9749 On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 . There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards. Come engage for a double session with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your orthopedic device company navigate the higher level of scrutiny. Session I – Overview of MDR Changes: when legacy products need to be evaluated acquisition of companies with existing products on the market difference between the EU and FDA requirements concerning technical documentation difference between notified bodies transferring challenges of products from one notified body to another changes in the regulation areas of higher expectations Session II – Overview of Clinical Requirements: key differences between MDR and MDD regarding clinical evaluation data from clinical investigations vs. data from literature review relevant changes regarding the demonstration of equivalence the additional scrutiny and requirements in the pre and post-market phase MEDDEV 2.7/1, Rev. 4 guidance document toward the transition from MDD to MDR This event is coordinated by the RAPS Florida chapte r and is intended to encourage knowledge sharing and community development. Refreshments will be available for all attendees and RAC holders may claim two RAC recertification credits . Feature Speakers: Matthias Fink, MD , clinical reviewer, Clinical Centre of Excellence at TÜV SÜD Max Singh, PhD global manager for Orthopedics, TÜV SÜD Registration Fees: RAPS Members: $20 Nonmember: $30 #FloridaChapter

  • DC/Baltimore Chapter: Speed Mentoring Session

    Feb 7, 5:30 PM - 8:00 PM
    Thursday, 7 February 2019 5:30- 8:30 pm EST RAPS Global Headquarters 5635 Fishers Lane Suite 400 Rockville, MD 20852 +1 301 770 2920 ext 200 Do you have questions about advancing your career in regulatory? Are you curious about the skills regulatory employers are seeking? Would you like to learn more about how Regulatory Affairs Certification (RAC) can help or how other programs at local colleges and universities? Or are you looking to transition into regulatory affairs? If so, come spend an evening engaging veteran professionals on these and other questions. RAPS believes in the power of mentoring and is committed to providing opportunities for seasoned professionals to engage with those new to the regulatory profession. To achieve this goal, the DC/Baltimore chapter invites you to participate in an innovative program, formatted to provide a fun and fulfilling experience for all involved. Think speed dating, except the engagement is between mentors and mentees. How Does it Work? We’ve recruited a handful of senior regulatory professionals, each with years of experience in regulatory. Our mentors will be seated in stationery positions with an empty chair in front of them. Mentees are to sit down opposite the mentor for the opportunity to ask the mentor a few career-related questions. Every five to seven minutes, a bell will sound, and the mentees will move on to the next mentor to ask the same, or a different set of questions. Some examples of potential questions/discussions topics that mentees should bring with them may include: How did you end up in regulatory? What skills to regulatory employers look for? How can I make myself a more attractive candidate? Are there any courses or training programs that you suggest? How can the RAC help my career? Do you have any specific suggestions breaking into regulatory? The rotational conversations ensure that everyone will have an opportunity to meet and interact with one another. After the interactions, a light meal will be available providing ample opportunity to continue the conversations and exchange contact information if appropriate. This event is coordinated by the RAPS DC/Baltimore chapter and is intended to promote knowledge sharing and engagement among regulatory professionals in our region. Dinner will be provided and RAC holders may claim two RAC recertification credits . Registration Information: Student: Free* Member: $20 Nonmember: $30 *To get student rate, contact RAPS Customer Service at support@raps.org or +1 301 770 2920 ext 200 #DC/BaltChapter

  • Introduction to Electronic Regulatory Submissions in the eCTD Format - February 2019

    Feb 12, 9:00 AM - 4:00 PM
    Introduction to Electronic Regulatory Submissions in the eCTD Format 12 February 2019 (9:00 am–4:00 pm EDT) 13 February 2019 (9:00 am–3:00 pm EDT) The Universities at Shady Grove 9630 Gudelsky Drive, Building II Rockville, MD 20850 Do you need to ensure your company’s compliance with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . Then this workshop is your first stop to learn all you need to know to help your company migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: • Different submission types • Which applications need to be submitted electronically • How to understand and follow the CTD structure • How to use the M4 series of guidances and granularity to generate compliant submissions • Agency-compliant PDF files and how to generate them • Which agency guidelines and technical specifications publishers need to follow • What tools are required to electronically submit your applications Join us for this two-day training that will answer your eCTD questions and help you get on a direct path to compliance. Registration Closes: 8 February 2019 Refund Deadline: 13 January 2019 RAC Credits: 8 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request.   Registration Fees to 14 January 2019 RAPS Members: $1,050 Nonmembers: $1,150 Registration from 15 January to 8 February 2019 RAPS Members: $1,150 Nonmembers: $1,250 Advance registration is required for this workshop and participants are encouraged to register early. Objectives & Audience Objectives After this program, participants will be able to: •Understand the acronyms and terms surrounding electronic submissions •Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD •Identify best practices with software used to generate electronic submission content •Produce MS Word and PDF documents that meet FDA guidelines •Obtain a basic understanding of what is required to transition into submitting in the eCTD format Who Should Attend The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the FDA electronic submission deadlines for eCTD that took effect May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation. Agenda •Define important terminology used in e-submissions •Provide a detailed breakdown of the CTD structure •Understand the M4 guidances (ICH) and FDA Technical Specifications •Learn how to create FDA-compliant MS Word documents •Learn how to create FDA-compliant PDF documents from differing sources •Review the workflow process using planners to produce an eCTD •Learn how to convert from a paper application to an eCTD application •Learn the basics of managing an electronic submissions project •Review the entire Lifecycle of an electronic submission from first steps to eCTD •Learn tips, tricks and best practices •What does eCTD readiness mean? NOTE: Program content may vary. Faculty Marianne Mowrer, regulatory submissions specialist, Mentara Inc. Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc. You may register for this workshop via mail or fax if it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 13 January 2019 Other Information: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact: Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Area Airports Washington Reagan Airport (DCA) Washington Dulles International Airport (IAD) Baltimore-Washington International Airport (BWI) Area Hotels The following hotels are located near The Universities at Shady Grove. Hilton Garden Inn Rockville 14975 Shady Grove Road Rockville, MD 20850 (240) 507-1800 Courtyard by Marriott Rockville 2500 Research Boulevard Rockville, MD 20850 (301) 670-6700 Radisson Hotel Washington DC - Rockville 3 Research Center Rockville, MD 20850 (301) 840-0200 Cancellations All cancellation requests must be submitted to raps@raps.org by 13 January 2019 . A 20% cancellation fee will be assessed. Please specify the name of the person registered and event title. RAPS is unable to accept cancellations by phone. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 29 January 2019 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Atlanta Chapter: The Basics of the 510(k) Submission Process

    Feb 13, 11:30 AM - 5:00 PM
    Wednesday, 13 February 2019 11:30 am - 5:00 pm EST Alcon Laboratories, Inc. 11460 Johns Creek Parkway Commons Building #3 Duluth, GA 30097 +1 678 415 3937 The RAPS Atlanta chapter invites you to come engage with others in your local regulatory community for a hands-on workshop to learn about the 510(k) submission process. Most medical devices in the US today are marketed under the premarket notification (510(k) authorities of the Federal Food, Drug and Cosmetic Act. In order to market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of: regulatory fundamentals practical guidance on how to develop, prepare and submit a 510(k) to FDA 510(k) submission types changes being discussed by FDA to this submission process how to engage with FDA Scheduled presentations include: Regulatory Fundamentals - Device Classification, Introduction to 510(k) and Types of 510(k)s Practical Guidance on How to Develop, Prepare and Submit a 510(k), Including Product Codes and Predicate Devices Practical Guidance on 510(k) Test Requirements, Software and eCopy Changes in the Submission Process and Engaging with FDA The workshop will also include case studies where attendees break out into groups based on experience to collectively classify a device, determine a predicate and the appropriate submission type and then create a high level 510(k) outline and strategy. This workshop, hosted by Alcon Laboratories, Inc. , is brought to you by the RAPS Atlanta Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Don’t miss this unique, hands-on opportunity to learn about the 510(k) submission process. Lunch will be provided to all attendees and RAC holders may claim five RAC recertification credits . Featured Speakers: Melissa O'Connor, MS, RAC, CTBS , vice president of quality assurance and regulatory affairs, StimLabs, LLC Grace Powers, MS, MBA, RAC , founder and principal consultant, Powers Regulatory Consulting Beatrice Wan, MBA, RAC , senior regulatory specialist, Becton Dickinson Registration Information: RAPS Members: $69 Nonmembers: $89 #AtlantaChapter

  • Intermediate Course for Regulatory Submissions in eCTD Format - February 2019

    Feb 14, 9:00 AM - 4:00 PM
    Intermediate Course for Regulatory Submissions in eCTD Format 14 February 2019 (9:00 am–4:00 pm PDT) 15 February 2019 (9:00 am–3:00 pm PDT) The Universities at Shady Grove 9630 Gudelsky Drive, Building II Rockville, MD 20852 If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements, this course is for you.Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: How to comply with the May 2018 electronic submissions requirements Which agency guidelines and technical specifications publishers need to follow How to apply ICH and regional requirements to your eCTD How to compile documents into the XML backbone of an eCTD, and lifecycle that application How to QC and validate an eCTD How metadata and study tagging files work Tips, tricks and best practices gathered from industry professionals How convert from a paper application to an eCTD How the new Module 1 (version 3.3) can be used for regulatory submissions What CTD readiness really means We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ. Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance. Registration Closes: 8 February 2019 Refund Deadline: 16 January 2019 RAC Credits: 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Objective s - At the conclusion of this program, participants will be able to: Identify best practices with software used to generate electronic submission content Understand the acronyms and terms surrounding eCTD and electronic submissions Apply ICH and regional requirements for the content of an eCTD submission Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA Obtain an understanding of what is required to transition into submitting in the eCTD format Who Should Attend This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. Agenda How to comply with the May 2018 electronic submission requirements Guidances that govern electronic submissions How to electronically submit to FDA Generating compliant PDF files—best practices in MS Word and Adobe Acrobat Hands-on compilation of an eCTD Module 1 differences between US and Rest of World Creating the initial sequence of an application Assigning the metadata required by the regional authority and ICH Lifecycling the application Publishing and validating the application Compiling will include: Study Tagging Files (STFs) Datasets SPLs (Structured Product Labeling) Granulated Clinical Study Reports (gCSR) Challenges with preparing compliant eCTD submissions Review and QC of the compiled application Common and avoidable errors that could get your submission rejected Tips, tricks and best practices gathered from industry professionals Converting from a paper application to an eCTD application What eCTD readiness really means NOTE: Program content may vary. Faculty: Elsmari Eggers , head of training and RA consulting, LORENZ Life Sciences Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Jared Lantzy , PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Registration Information: Students will need to bring their own laptops. Registration to 16 January 2019 RAPS Members: $1,150 Nonmembers: $1,250 Registration from 17 January to 8 February 2019 RAPS Members: $1,250 Nonmembers: $1,350 Advance registration is required for this workshop and we recommend that you register early. RAPS is unable to accept onsite registrations. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 16 January 2019 Other Information: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact: Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 252 Area Airports Washington Reagan Airport (DCA) Washington Dulles International Airport (IAD) Baltimore Washington International Airport (BWI) Area Hotels The following hotels are located near the The Universities at Shady Grove. Hilton Garden Inn Rockville 14975 Shady Grove Road Rockville, MD 20850 (240) 507-1800 Courtyard by Marriott Rockville 2500 Research Boulevard Rockville, MD 20850 (301) 670-6700 Radisson Hotel Washington DC - Rockville 3 Research Center Rockville, MD 20850 (301) 840-0200 Cancellation All cancellation requests must be submitted to raps@raps.org by 15 January 201 9. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 31 January 2019 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • NY/NJ Chapter: Webcast and Virtual Q&A: Introduction to China Medical Device Regulations, Including

    Feb 15
    Online Question & Answer Session: 15 February 2019 In March of 2018, China’s State Council unveiled a draft plan to reshuffle government ministries, with the China Food and Drug Administration (CFDA), along with several other administrations, restructured as the National Market Supervision Administration. While China’s medical device regulatory standards are becoming more harmonized with international standards, the Chinese registration process still poses significant challenges for western device firms. This virtual presentation will provide a high-level summary of the registration procedure in China, including an overview of each step in the process for registering a device or IVD. And, as China is going through a major reform of its regulations , this presentation will attempt to summarize both the challenges and opportunities that the new regulations will bring. How does this webcast and virtual Q&A work? Step One: Watch the on-demand webcast between now and Thursday, 14 February. Step Two: Once you’ve watched the webcast, post your thoughts or questions for the speaker in the online community for this activity. (Instructions will be provided upon registering.) Step Three: The Speaker will log-on to the online community on Friday, 15 February to answer questions and respond to inquiries. This is not a live Q&A. All participants will have access to the recording and virtual Q&A session for one year. This virtual activity was developed by the RAPS New York/New Jersey chapter to help regulatory professionals be more prepared to register products in China. Featured Speaker: Lin Lin, regulatory affairs manager, Ortho Clinical Diagnostics Registration Information: RAPS Members: $20 Nonmembers: $40 #NY/NJChapter

  • Chicago Chapter: Navigating the Regulatory Challenges of Companion Diagnostics and Combination Produ

    Feb 21, 5:30 PM - 8:30 PM
    Thursday, 21 February 2019 5:30-8:30 pm CST AbbVie One 26525 North Riverwoods Blvd First Floor, São Paulo Conference Room North Chicago, IL 60064-6220 +1 800 255 5162 Join regulatory professionals from your local area for presentations on these two important topics that cover companion diagnostics and combination products. A companion diagnostic provides information that is essential for the safe and effective use of a corresponding drug or biological product. Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products. Postmarketing Safety Reporting--Understanding the Draft Guidance: An Industry Perspective As an industry representative, our speaker will highlight some areas where the guidance appears to have added clarity, and other areas where clarity might still be needed with regards to PMSR requirements. In addition, the presentation will provide an overview of key challenges and suggested solutions that will help your company be more prepared for implementation. Navigating Regulatory Challenges in the Companion Diagnostic Co-Development Process The use of companion diagnostics (CDx) has become increasingly common in recent years due to advances in diagnostics and therapies related to oncology, inflammation and autoimmune diseases. Coupled with the benefit of customizing treatment options for individual patients, assuring positive outcomes and avoiding side effects, CDx offers a revolutionary approach to improving patient care. However, the need to have both the drug and device approved for market at the same time and the unique regulatory requirements adds to the complexity of the co-development process. Successful launch of CDx products relies on regulatory professionals who can navigate the challenges exclusive to CDx. The presentation will provide participants with an introduction to CDx and the important issues faced by regulatory professionals working in the CDx space. This program is brought to you by the RAPS Chicago chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits . Featured Speakers: Khaudeja Bano, MD , head of medical affairs, Abbott Molecular Vihanga Pahalawatta, PhD , regulatory affairs senior specialist, Abbott Molecular Registration Information: Prior to 15 February: Member: $30 Nonmember: $45 On or After 15 February: Member: $40 Nonmember: $55 #ChicagoChapter #AtlantaChapter #BostonChapter #DC/BaltChapter #Pharmaceuticals #ChicagoChapter #DC/BaltChapter #DC/BaltChapter #FloridaChapter #IndianaChapter #NY/NJChapter #AtlantaChapter #VancouverChapter #WisconsinChapter

  • New York/New Jersey Chapter: Analytical and Clinical Design Considerations for IVDs and Companion Di

    Feb 21, 5:30 PM - 8:30 PM
    Thursday, 21 February 2019 5:30–8:30 pm EST Ortho Clinical Diagnostics 1001 North US Route 202 Raritan, NJ 08853 +1 800 828 631 Join regulatory professionals from your local area for an evening of networking and to hear an interactive presentation from an FDA representative on an important topic. The speaker’s presentation will explore design issues related to analytical studies and how to design precision studies in a more optimal way, including whether the type of assay (either quantitative or qualitative) is important for the study design, and how to use surrogate samples in analytical studies. The speaker will also discuss what additional issues should be considered for the inclusion of archived samples in the clinical performance study. For companion diagnostic devices, bridging studies will be examined as well. This event, hosted by Ortho Clinical Diagnostics, is brought to you by the New York/New Jersey and is intended to facilitate networking and knowledge sharing among regulatory professionals in the region. A light meal will be available for all attendees and RAC holders may claim two RAC recertification credits . Featured Speaker: Dr. Marina V. Kondratovich, PhD , associate director, clinical studies, Office of In Vitro Diagnostic and Radiological, CDRH, FDA Registration Fees: RAPS Members: $35 Nonmember: $50 #NY/NJChapter

  • Sponsored Webcast: Successfully Integrating Cybersecurity Risk Management into International Regulat

    Feb 27, 12:00 PM - 1:00 PM
    27 February 2019 12:00 – 1:00pm EST Registration Information Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year. This webcast is device focused and is only intended to be applicable to the medical device sector. Global regulatory submissions are becoming increasingly more stringent related to cybersecurity requirements. One consistent expectation is that manufacturers provide evidence of effective cybersecurity risk management. Being able to interpret what countries are expecting and how they leverage cybersecurity risk management is becoming critical for successful submissions. It is also imperative to understand that safety risk management alone is insufficient for cybersecurity risk management. This webcast will focus on three aspects: How cybersecurity risk management impacts international regulatory submissions What international regulatory submissions are looking for from cybersecurity risk management Cybersecurity Risk Management 101 – What is the difference between safety risk management and cybersecurity risk management and what should your cybersecurity risk management include Learning Level: Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon the webcast's conclusion, you will be able to: Understand the basic elements of cybersecurity risk management Understand how cybersecurity risk management plays a role in submissions across the globe Understand the difference between cybersecurity risk management and safety risk management Who should attend ? Product Security Professionals Risk Management Professionals Regulatory Affairs Professionals within Medical Device Industry Speakers Nicholas Werner , senior scientific advisor, regulatory affairs, Network Partners Michelle Jump , vice president of cyber program initiatives, Nova Leah Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin-top:0in; mso-para-margin-right:0in; mso-para-margin-bottom:8.0pt; mso-para-margin-left:0in; line-height:107%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri",sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;}

  • Virtual Program: Developing and Sustaining Quality Management Systems in Compliance with Pharma Indu

    Mar 12, 11:00 AM - 4:00 PM
    12 March 2019 11:00 am – 4:00 pm EDT Registration Information Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year. Register By 11 Feb Register After 11 Feb RAPS Members: $295 Nonmembers: $355 RAPS Members: $395 Nonmember: $475 Description Over the past few years there has been a growing expectation and increased standardization for Quality Management Systems (QMS) as it relates to clinical research in the pharma industry. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 revision was just one example of a response to the need and demand for a more robust and documented system to ensure that procedures are established, and processes are in place to monitor compliance and analyze issues when they occur. This program will address the growing requirements and expectations as it relates to root cause analysis, corrective and preventative action plans and implementation, aspects of a robust quality assurance program and how quality control can minimize errors and other quality issues. This program will support both the new and seasoned QMS manager or stakeholder to better understand the requirements, current industry trends for application and give them sample tools that can be used for quality management. Learning Level: Intermediate : Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Learning Objectives Upon conclusion of the program, you will be able to: Identify and interpret regulatory requirements and industry standards as it relates to the development and maintenance of a QMS. Provide input to a pharma organization regarding the rationale for a QMS including Quality Assurance and Quality Control programs. Understand the basic elements of a root cause analysis (RCA) and corrective and preventative action (CAPA) plan. Choose at least one tool for performing and documenting an RCA and/ or CAPA. Who should attend Quality assurance professionals Regulatory professionals Clinical professionals Vendor/ subcontractor personnel Speakers Treena Jackson, MS-QA/RA, MA, CQA, RAC, CSSGB, quality assurance manager, RTI Health Solutions Treena Jackson is a consultant, instructor, author and a Quality Assurance Manager in the RTI‑Health Solution Office of Quality Assurance. Jackson has been a quality professional for more than 17 years. Her experience includes managing quality and regulatory systems and projects in global pharmaceutical companies and contract research organizations while participating in a wide variety of therapeutic areas. She has also served as an independent consultant for pharmaceutical companies participating in domestic and international trial programs, supporting regulatory functions, as well as initiatives to develop and improve corporate quality-management programs. Jackson has provided, developed and presented training programs to quality and research staff internationally. She has over 12 years of experience as a renowned adjunct professor, author and lecturer of quality, regulatory and clinical research topics for area universities and professional organizations. She currently teaches with Barnett International on both quality and regulatory topics. Additional Speakers TBA

  • Utah Chapter: Transitioning to the New EU MDR/IVDR–Post-Market Surveillance, Clinical and Usability

    Mar 28, 8:00 AM - 11:30 AM
    Thursday, 28 March 2019 8:00-11:30 am MDT MasterControl 6350 South 3000 East Sixth Floor Salt Lake City, UT 84121 +1 801 942 4000 On 5 May 2017, the European Commission adopted the new  Medical Device Regulation (MDR) 2017/745  and the new  In Vitro Diagnostic Regulation (IVDR) 2017/756 . There is a three-year transition period, ending in May 2020 for the MDR, and a five-year transition period, ending in May 2022 for the IVDR, after which the respective regulations will take effect. Device manufacturers have the duration of the transition period to update their technical documents and processes to meet the standards. Join other regulatory, quality and life science professionals from your region for an interactive breakfast session on this important topic. You’ll hear from three seasoned professionals on the sections of the regulation that companies struggle with most: chapter VI,  Clinical Evaluation and Clinical Investigations  and chapter VII,  Post-Market Surveillance, Vigilance and Market Surveillance . The parallel chapters of the IVDR will also be discussed. By attending this session, participants will gain a better understanding of: How will devices and diagnostics, currently sold in the EU market, be impacted by the new regulatory changes? What clinical research and risk assessment methods should new product developers consider before selling in the EU?    What areas (Quality, Regulatory and Clinical) are impacted by the new Medical Device Regulation? What are some planning steps to consider when beginning the implementation process? This workshop, hosted by  MasterControl  and  BioUtah's Regulatory, Compliance and Quality Committee ,  is brought to you by the  RAPS Utah chapter  and is intended to promote knowledge sharing and networking among professionals in the regulatory and related industry. Breakfast will be provided to all attendees and RAC holders may claim three  RAC recertification credits .  Featured Speakers: Linda Chatwin, RAC, JD , senior customer solutions consultant, Health Sciences Division, Emergo, a UL Company Dr. Kristen Kanack, PhD ,  senior vice president, regulatory and clinical affairs, BioFire Diagnostics, LLC  Dr. Michael Rinck, PhD , managing director, pharmacist and microbiologist, Promedt Consulting GmbH Registration Information:                            RAPS Members: $30 Nonmember: $50 #UtahChapter

  • Atlanta Chapter: Medical Device Risk Management (ISO 14971) - Understanding the New Versions

    May 1, 9:00 AM - 5:00 PM
    Wednesday, 1 May 2019 9:00 am-5:00 pm EST Alcon Laboratories, Inc. 11460 Johns Creek Parkway Commons Building #3 Duluth, GA 30097 +1 678 415 3937 In 2019, the International Organization for Standardization (ISO) plans to issue a new version of ISO 14971 . This new version also affects the EU, resulting in new annexes for the three directives and two regulations. While the new version doesn’t make major changes to the risk management process, the details affect current practice. Device manufacturers will update risk management activities resulting in new procedures, new device risk management plans and revised risk management files. This workshop will provide the information you need to understand the new versions (international and EU) and effectively implement them. This is particularly important since the EU regulations (MDR and IVDR) also change risk management requirements. The workshop will begin with an overview of risk management to provide a common framework for participants. This includes definitions from the new standard and illustrations of their application. The speaker will then explore the relationship between the Risk Management System (RMS) and the Quality Management System (QMS), specifically how these essential elements of the regulatory framework must work in conjunction with one another. The presentation will also cover one of the areas of common misunderstanding: the relationship of the hazards analyzed in risk management and failures analyzed in a Failure Mode, Effects, and Criticality Analysis (FMECA), and why the FMECA is the wrong tool for this application. And finally, the speaker will review the risk management process in the new standard as well as the relationship with the EU requirements. The new version is a process standard, so we’ll look at each process step and explain how to implement it. Workshop participants will receive some tools to assist with implementation, including an Excel workbook to implement the process and a template for a risk management plan. This interactive program, hosted by Alcon Laboratories, Inc. , is brought to you by the RAPS Atlanta Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Don’t miss this unique opportunity for a deep dive into medical device risk management. Lunch will be provided to all attendees and RAC holders may claim six RAC recertification credits . Featured Speakers: Dan O'Leary CBA, CQA, CQE, CRE, CSSBB, CIRM , president, Ombu Enterprises, LLC Registration Information: Prior to 17 April: RAPS Members: $89 Nonmember: $109 ​ On or After 17 April: RAPS Members: $99 Nonmember: $119

  • Executive Development Program at the Kellogg School of Management

    May 5, 8:00 AM - 5:00 PM
    Advance registration is required for Executive Development Program at the Kellogg School of Management . Participants are encouraged to register early. Onsite registrations are not accepted. » Register Online » Registration Form (PDF) for registration by mail or fax Program Dates : 5-8 May 2019 Registration Closes : 28 April 2019 Refund Deadline : 5 April 2019 Meeting Location : Kellogg School of Management 2169 Campus Dr, James L. Allen Center Evanston, Illinois, USA, 60208-0875 Accommodations Rooms and meals are included in the program price. Registrants will be housed on campus at the James Allen Conference Center. All meals will also be served in the Allen Center. Registration Fees : September 2018 - 31 December 2018 : Member Price: $7,850.00 Enterprise Price: $7450.00 List Price: $8,300.00 1 January 2019 – 28 April : Member Price: $8,100.00 Enterprise: $7,700.00 List Price: $8,550.00 If it is your preference, please use the registration form to register by mail, email or fax. If you or your company will submit your registration via mail, please ensure that you include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Question s? Call RAPS Solutions Center at +1 301 770 2920, ext. 200.

  • Introduction to Electronic Regulatory Submissions in the eCTD Format - June 2019

    Jun 11, 9:00 AM - 4:00 PM
    Introduction to Electronic Regulatory Submissions in the eCTD Format 11 June 2019 (9:00 am--4:00 pm CT) 12 June 2019 (9:00 am–4:00 pm CT) Loyola University Chicago- Water Tower Campus Philip H. Corboy Law Center 25 East Pearson Street Chicago, IL 60611 Do you need to ensure your company’s compliance with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . Then this workshop is your first stop to learn all you need to know to help your company migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: • Different submission types • Which applications need to be submitted electronically • How to understand and follow the CTD structure • How to use the M4 series of guidances and granularity to generate compliant submissions • Agency-compliant PDF files and how to generate them • Which agency guidelines and technical specifications publishers need to follow • What tools are required to electronically submit your applications Join us for this two-day training that will answer your eCTD questions and help you get on a direct path to compliance. Registration Closes: 4 June 2019 Refund Deadline: 12 May 2019 RAC Credits: 8 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request.   Registration Fees to 12 May 2019 RAPS Members: $1,050 Nonmembers: $1,150 Registration from 13 May to 4 June 2019 RAPS Members: $1,150 Nonmembers: $1,250 Advance registration is required for this workshop and participants are encouraged to register early. Objectives & Audience Objectives After this program, participants will be able to: •Understand the acronyms and terms surrounding electronic submissions •Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD •Identify best practices with software used to generate electronic submission content •Produce MS Word and PDF documents that meet FDA guidelines •Obtain a basic understanding of what is required to transition into submitting in the eCTD format Who Should Attend The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the FDA electronic submission deadlines for eCTD that took effect May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation. Agenda •Define important terminology used in e-submissions •Provide a detailed breakdown of the CTD structure •Understand the M4 guidances (ICH) and FDA Technical Specifications •Learn how to create FDA-compliant MS Word documents •Learn how to create FDA-compliant PDF documents from differing sources •Review the workflow process using planners to produce an eCTD •Learn how to convert from a paper application to an eCTD application •Learn the basics of managing an electronic submissions project •Review the entire Lifecycle of an electronic submission from first steps to eCTD •Learn tips, tricks and best practices •What does eCTD readiness mean? NOTE: Program content may vary. Faculty Marianne Mowrer, regulatory submissions specialist, Mentara Inc. Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc. You may register for this workshop via mail or fax if it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 12 May 2019 Other Information: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact: Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Area Airport Chicago Midway International Airport (MDW) O'Hare International Airport (ORD) Area Hotels The following hotels are located near Loyola University Chicago. Loyola Lodging at Baumhart Hall (managed by Loyola University) 26 East Pearson Street Chicago, IL 60611 (312) 915-6178 The Whitehall Hotel 105 East Delaware Place Chicago, IL 60611 (312) 944-6300 The Talbott 20 East Delaware Place Chicago, IL 60611 (312) 397-3619 Cancellations All cancellation requests must be submitted to raps@raps.org by 12 May 2019 . A 20% cancellation fee will be assessed. Please specify the name of the person registered and event title. RAPS is unable to accept cancellations by phone. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 28 May 2019 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Intermediate Course for Regulatory Submissions in eCTD Format - June 2019

    Jun 13, 9:00 AM - 4:00 PM
    Intermediate Course for Regulatory Submissions in eCTD Format 13 June 2019 (9:00 am–4:00 pm CT) 14 June 2019 (9:00 am–4:00 pm CT) Loyola University Chicago- Water Tower Campus Philip H. Corboy Law Center 25 East Pearson Street Chicago, IL 60611 If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements, this course is for you.Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: How to comply with the May 2018 electronic submissions requirements Which agency guidelines and technical specifications publishers need to follow How to apply ICH and regional requirements to your eCTD How to compile documents into the XML backbone of an eCTD, and lifecycle that application How to QC and validate an eCTD How metadata and study tagging files work Tips, tricks and best practices gathered from industry professionals How convert from a paper application to an eCTD How the new Module 1 (version 3.3) can be used for regulatory submissions What CTD readiness really means We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ. Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance. Registration Closes: 6 June 2019 Refund Deadline: 14 May 2019 RAC Credits: 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Objective s - At the conclusion of this program, participants will be able to: Identify best practices with software used to generate electronic submission content Understand the acronyms and terms surrounding eCTD and electronic submissions Apply ICH and regional requirements for the content of an eCTD submission Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA Obtain an understanding of what is required to transition into submitting in the eCTD format Who Should Attend This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. Agenda How to comply with the May 2018 electronic submission requirements Guidances that govern electronic submissions How to electronically submit to FDA Generating compliant PDF files—best practices in MS Word and Adobe Acrobat Hands-on compilation of an eCTD Module 1 differences between US and Rest of World Creating the initial sequence of an application Assigning the metadata required by the regional authority and ICH Lifecycling the application Publishing and validating the application Compiling will include: Study Tagging Files (STFs) Datasets SPLs (Structured Product Labeling) Granulated Clinical Study Reports (gCSR) Challenges with preparing compliant eCTD submissions Review and QC of the compiled application Common and avoidable errors that could get your submission rejected Tips, tricks and best practices gathered from industry professionals Converting from a paper application to an eCTD application What eCTD readiness really means NOTE: Program content may vary. Faculty: Elsmari Eggers , head of training and RA consulting, LORENZ Life Sciences Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Jared Lantzy , PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Registration Information: Students will need to bring their own laptops. Registration to 14 May 2019 RAPS Members: $1,150 Nonmembers: $1,250 Registration from 15 May to 6 June 2019 RAPS Members: $1,250 Nonmembers: $1,350 Advance registration is required for this workshop and we recommend that you register early. RAPS is unable to accept onsite registrations. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 14 May 2019 Other Information: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact: Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 252 Area Airport Chicago Midway International Airport (MDW) O'Hare International Airport (ORD) Area Hotels The following hotels are located near Loyola University Chicago. Loyola Lodging at Baumhart Hall (managed by Loyola University) 26 East Pearson Street Chicago, IL 60611 (312) 915-6178 The Whitehall Hotel 105 East Delaware Place Chicago, IL 60611 (312) 944-6300 The Talbott 20 East Delaware Place Chicago, IL 60611 (312) 397-3619 Cancellation All cancellation requests must be submitted to raps@raps.org by 14 May 2019 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 30 May 2019 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Introduction to Electronic Regulatory Submissions in the eCTD Format - November 2019

    Nov 12, 9:00 AM - 4:00 PM
    Introduction to Electronic Regulatory Submissions in the eCTD Format 12 November 2019 (9:00 am–4:00 pm ET) 13 November 2019 (9:00 am–4:00 pm ET) The Universities at Shady Grove 9630 Gudelsky Drive, Building II Rockville, MD 20850 Do you need to ensure your company’s compliance with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . Then this workshop is your first stop to learn all you need to know to help your company migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: • Different submission types • Which applications need to be submitted electronically • How to understand and follow the CTD structure • How to use the M4 series of guidances and granularity to generate compliant submissions • Agency-compliant PDF files and how to generate them • Which agency guidelines and technical specifications publishers need to follow • What tools are required to electronically submit your applications Join us for this two-day training that will answer your eCTD questions and help you get on a direct path to compliance. Registration Closes: 5 November 2019 Refund Deadline: 13 October 2019 RAC Credits: 8 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request.   Registration Fees to 13 October 2019 RAPS Members: $1,050 Nonmembers: $1,150 Registration from 14 October to 5 November 2019 RAPS Members: $1,150 Nonmembers: $1,250 Advance registration is required for this workshop and participants are encouraged to register early. Objectives & Audience Objectives After this program, participants will be able to: •Understand the acronyms and terms surrounding electronic submissions •Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD •Identify best practices with software used to generate electronic submission content •Produce MS Word and PDF documents that meet FDA guidelines •Obtain a basic understanding of what is required to transition into submitting in the eCTD format Who Should Attend The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the FDA electronic submission deadlines for eCTD that took effect May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation. Agenda •Define important terminology used in e-submissions •Provide a detailed breakdown of the CTD structure •Understand the M4 guidances (ICH) and FDA Technical Specifications •Learn how to create FDA-compliant MS Word documents •Learn how to create FDA-compliant PDF documents from differing sources •Review the workflow process using planners to produce an eCTD •Learn how to convert from a paper application to an eCTD application •Learn the basics of managing an electronic submissions project •Review the entire Lifecycle of an electronic submission from first steps to eCTD •Learn tips, tricks and best practices •What does eCTD readiness mean? NOTE: Program content may vary. Faculty Marianne Mowrer, regulatory submissions specialist, Mentara Inc. Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc. You may register for this workshop via mail or fax if it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 13 October 2019 Other Information: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact: Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291 Area Airports Washington Reagan Airport (DCA) Washington Dulles International Airport (IAD) Baltimore-Washington International Airport (BWI) Area Hotels The following hotels are located near The Universities at Shady Grove. Hilton Garden Inn Rockville 14975 Shady Grove Road Rockville, MD 20850 (240) 507-1800 Courtyard by Marriott Rockville 2500 Research Boulevard Rockville, MD 20850 (301) 670-6700 Radisson Hotel Washington DC - Rockville 3 Research Center Rockville, MD 20850 (301) 840-0200 Cancellations All cancellation requests must be submitted to raps@raps.org by 13 October 2019 . A 20% cancellation fee will be assessed. Please specify the name of the person registered and event title. RAPS is unable to accept cancellations by phone. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 29 October 2019 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

  • Intermediate Course for Regulatory Submissions in eCTD Format - November 2019

    Nov 14, 9:00 AM - 4:00 PM
    Intermediate Course for Regulatory Submissions in eCTD Format 14 November 2019 (9:00 am–4:00 pm ET) 15 November 2019 (9:00 am–4:00 pm ET) The Universities at Shady Grove 9630 Gudelsky Drive, Building II Rockville, MD 20852 If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements, this course is for you.Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn: How to comply with the May 2018 electronic submissions requirements Which agency guidelines and technical specifications publishers need to follow How to apply ICH and regional requirements to your eCTD How to compile documents into the XML backbone of an eCTD, and lifecycle that application How to QC and validate an eCTD How metadata and study tagging files work Tips, tricks and best practices gathered from industry professionals How convert from a paper application to an eCTD How the new Module 1 (version 3.3) can be used for regulatory submissions What CTD readiness really means We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ. Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance. Registration Closes: 7 November 2019 Refund Deadline: 15 October 2019 RAC Credits: 10 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request. Objective s - At the conclusion of this program, participants will be able to: Identify best practices with software used to generate electronic submission content Understand the acronyms and terms surrounding eCTD and electronic submissions Apply ICH and regional requirements for the content of an eCTD submission Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA Obtain an understanding of what is required to transition into submitting in the eCTD format Who Should Attend This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. Agenda How to comply with the May 2018 electronic submission requirements Guidances that govern electronic submissions How to electronically submit to FDA Generating compliant PDF files—best practices in MS Word and Adobe Acrobat Hands-on compilation of an eCTD Module 1 differences between US and Rest of World Creating the initial sequence of an application Assigning the metadata required by the regional authority and ICH Lifecycling the application Publishing and validating the application Compiling will include: Study Tagging Files (STFs) Datasets SPLs (Structured Product Labeling) Granulated Clinical Study Reports (gCSR) Challenges with preparing compliant eCTD submissions Review and QC of the compiled application Common and avoidable errors that could get your submission rejected Tips, tricks and best practices gathered from industry professionals Converting from a paper application to an eCTD application What eCTD readiness really means NOTE: Program content may vary. Faculty: Elsmari Eggers , head of training and RA consulting, LORENZ Life Sciences Nora Keeling , MS, QC and regulatory submission consultant, Mentara Inc. Jared Lantzy , PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences Marianne Mowrer , regulatory submissions specialist, Mentara Inc. Registration Information: Students will need to bring their own laptops. Registration to 15 October 2019 RAPS Members: $1,150 Nonmembers: $1,250 Registration from 16 October to 7 November 2019 RAPS Members: $1,250 Nonmembers: $1,350 Advance registration is required for this workshop and we recommend that you register early. RAPS is unable to accept onsite registrations. If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200. Refund Deadline: 15 October 2019 Other Information: RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Program Contact: Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 252 Area Airports Washington Reagan Airport (DCA) Washington Dulles International Airport (IAD) Baltimore Washington International Airport (BWI) Area Hotels The following hotels are located near the The Universities at Shady Grove. Hilton Garden Inn Rockville 14975 Shady Grove Road Rockville, MD 20850 (240) 507-1800 Courtyard by Marriott Rockville 2500 Research Boulevard Rockville, MD 20850 (301) 670-6700 Radisson Hotel Washington DC - Rockville 3 Research Center Rockville, MD 20850 (301) 840-0200 Cancellation All cancellation requests must be submitted to raps@raps.org by 15 October 2019 . RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 31 October 2019 . If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.