2 Day Seminar: eCTD Submissions of IND and NDA/BLA to US FDA, EU and Canada (COM)

An Interative Workshop Presented BY WCS & Peggy J. Berry, MBA, RAC, (Synergy Consulting)

Course"eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS.

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

Why You should Attend The Session

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD

Areas Covered

•    Overview of the drug development program and source of relevant submission documents
•    Discussion of the roles and responsibilities for CTD preparation
•    Review of the CTD format requirements
•    Discussion on the successful transition from other formats to the CTD
•    Placement of content into the CTD format; including less obvious items
•    Review of different requirements across regions (US, EU, Canada)
•    Implementing tools for the project management of CTD preparation and publishing
•    Technical requirements for an eCTD submission
•    Document naming requirements
•    Building the folder structure
•    Internal document requirements for the eCTD
•    Performi