Do you need to comply with the impending 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: | 14-15 July 2020 |
| Meeting Location: | The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850 |
| Registration Closes: | 7 July 2020 |
| Refund Deadline: | 14 June 2020 |
| 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 14 June 2020
RAPS Members: $1,050
Nonmembers: $1,150
Registration from 15 June to 7 July 2020
RAPS Members: $1,150
Nonmembers: $1,250
Advance registration is required for this workshop. Participants are encouraged to register early.
|
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 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 2020.
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 series of guidance (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.
Speakers
Marianne Mowrer, regulatory submissions specialist, Mentara Inc.
Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc.
NOTE: Students must bring their own laptop for this training; RAPS does not supply equipment for tis event.
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.
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)
Cancellation
All cancellation requests must be submitted to raps@raps.org by 14 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.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org by 30 June 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.