Compiling regulatory dossiers for device registrations is time-consuming and expensive. With the constant changes in the regulatory landscape, it is good to know the expectations and receive FDA feedback for regulatory strategy including predicate selection, technical or analytical validation and clinical evidence prior to conducting verification, validation, and clinical studied. The U.S. Food and Drug Administration (FDA) offers several mechanisms through which a manufacturer can directly request feedback from the FDA regarding proposed study designs and strategies for medical devices/IVDs as part of their Q-submission program.
This 2-day workshop will review the multiple types of pre-submissions, or Q-submissions, available to manufacturers and how to leverage these to reduce the time and costs to bring medical devices to market in the U.S.
Registration Fees & Deadlines
1 November 2023 – 29 January 2024: Member €975 | Nonmember €1,155
30 January 2024 – 29 February 2024: Member €1,155 | Nonmember €1,350
Learning Objectives
- Identify the Q-submission options offered by the FDA for obtaining direct feedback on proposed devices and recognize when the different types of Q-submissions can be used
- Construct meaningful questions to obtain the necessary feedback to move forward with the next steps in the regulatory pathway
- Describe the content necessary to complete the different types of Q-submissions
- Appy learning to example devices and scenarios
Case studies will include both medical and IVD device
examples.
Audience 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?
Regulatory Affairs Professionals
Agenda
Day 1- 29 February 2024
- Introduction to FDA’s Q-submission Program – What is a Q submission? What types of Q-submissions are available?
- Q-submission process – How do I work with FDA to submit, correspond, and close out my Q-submission?
- How to effectively use Q-submissions in your regulatory strategy and tips for successful Q-submissions
- Case study exercise – Determine regulatory strategy and appropriate Q-submission for example cases
Day 2 – 1 March 2024
- Contents of Q-submissions
- Q-submission feedback and meetings
- Case study exercise – determine appropriate Q-submission content and questions for FDA example cases
- Panel Q&A
Speakers
Christie Hughes, MPH, MSL(ASCP)
Principal Consultant, IVD Expert, Qserve Group
Christie Hughes, MPH, MLS(ASCP) is a Principal Consultant and IVD Expert with Qserve Group who has over 25 years of experience in the in vitro diagnostic (IVD) medical device industry. With a degree in medical laboratory science, she began her career in hospital clinical laboratories. Upon moving into industry, Christie worked in various quality and compliance roles at small and startup companies where she established their quality management systems (QMS) compliant with ISO 9001, ISO 13485, and FDA QSR requirements. To learn other aspects of the industry, Christie led commercial and post-launch phases for a molecular test as a Product Manager before moving into Regulatory Affairs where she developed and executed domestic and international regulatory strategies for IVD instruments, software, and multiplexed assays (protein and molecular). After many years in various roles in industry and earning her master’s in public health degree in epidemiology, Christie moved into consulting where she continues to leverage her experience and knowledge to determine elegant solutions for clients’ QMS and regulatory affairs challenges. Christie’s expertise includes regulatory strategy, regulatory submissions, design controls, risk management, QMS implementation, and conducting audits with a focus on compliance with regulations covering the United States (FDA) and Europe (EU IVDR). Her most recent work involves assisting clients with transitioning their technical documentation for legacy IVD devices and assessing their QMS for compliance with EU IVDR requirements.
Lorry Weaver, MLS(ASCP), CLS
Principal Consultant, Qserve Group
Lorry thrives on providing strategic perspectives from a manufacturer’s point of view, having served on Executive Leadership teams at previous companies. Areas of expertise include; global regulatory strategy, regulatory planning, product development life-cycle regulatory applications, and team management.
Her background includes novel and traditional medical devices, as well as in vitro diagnostics across a wide product portfolio. She specializes in global regulatory strategy and planning, design control process and implementation consultation, US FDA submissions (pre-submissions, IDE, 510(k), PMA) and CE-Mark Technical File analyses for EU market access.
Lorry has been in the medical industry for over 30 years, working in large multi-national corporations, mid-sized companies, and clinical laboratories. Primary product areas include: cardiovascular devices and implants, renal devices, ultrasound, and in vitro diagnostics. Lorry's knowledge spans an international level, having had global responsibilities in the US, Europe, and Japan. She earned her BS in Microbiology with a minor in Chemistry from Northern Arizona University, and an MBA at California State University-Sacramento. Additionally, she is a licensed Medical Laboratory Scientist and Clinical Laboratory Scientist with ASCP, NCA, and State of California.
Natalie Batty
Senior Regulatory Affairs Specialist, Aignostics, GmbH
Natalie Batty has over 8 years of regulatory and clinical affairs experience working with in vitro diagnostic devices. She has completed FDA submissions (de novos, 510ks, and Emergency Use Authorizations) and has prepared IVD documentation for Canadian and European regulatory agencies.
Natalie started her career in Research and Development working with PCR-based IVDs, eventually serving as a regulatory affairs manager. In this role she was responsible for the preparation and management of US regulatory submissions, labeling, and post market surveillance and vigilance. Working as a consultant, she has assisted companies to comply with US and EU regulations on clinical evaluations and performance studies. She is well-versed in Good Clinical Practice and IVD clinical trial set-up and conduct.
Complementing this, Natalie is a certified lead auditor for ISO 13485 experienced in quality management system set-up and product risk management according to ISO 14971. Natalie has a strong scientific background with a Bachelor’s degree in Biology and Chemistry and a Master’s degree in Public Health from Westminster College (Salt Lake City, Utah). Natalie is currently based in Germany and working as a Senior Regulatory Affairs Specialist at Aignostics, GmbH.
Accommodations & Travel Information
Hilton Rotterdam
Weena 10
Rotterdam, 3012 CM
Netherlands
Check-in Date: 26 February 2024 | Check-out Date: 28 February 2024
Booking Information: RAPS has negotiated a rate of €179 including VAT. Please note there is an additional 6.5% city tax per room per night.
Reserve your room here
Book by 26 January for best availability.
Cancellations and Refunds
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.
All requests for cancellations must be received in writing at support@raps.org by 11:59 pm Eastern Time on 30 January 2024. Requests received by 1 January will be assessed a 10% fee. Requests received between 2 January and 30 January will be assessed a 50% fee. Cancellation requests received after 30 January will be non-refundable, except in cases of documented medical emergencies.
Refunds will not be issued for no-shows.
Proof of Attendance
A certificate of attendance will be sent after the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org