Do you have a working knowledge of the CTD structure and need to learn how to correctly apply it to electronic submissions, or do you need to know what is required to comply with the FDA’s May 2020 guidances, this course is for you.
Effective May 2020 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 2020 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: | 16-17 July 2020 |
| Meeting Location: | The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850 |
| Registration Closes: | 9 July 2020 |
| Refund Deadline: | 16 June 2020 |
| 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. |
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 2020 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: Students must bring their own laptops to this training session to access materials provided on the USB port provided.
Speakers
Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc.
Marianne Mowrer, regulatory submissions specialist, Mentara Inc.
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 16 June 2020
RAPS Members: $1,150
Nonmembers: $1,250
Registration from 17 June to 9 July 2020
RAPS Members: $1,250
Nonmembers: $1,350
Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.
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 June 2020
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
Accommodation Options: Below is a list of nearby hotel properties near host venue.
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
Area Airports
Washington Reagan Airport (DCA)
Washington Dulles International Airport (IAD)
Baltimore Washington International Airport (BWI)
All cancellation requests must be submitted to raps@raps.org by 16 June 2020. 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 by this stated date.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org by 2 July 2020.
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.