2-Day Workshop by Ex-FDA Official: eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (Burlingame, CA, United States - May 31st-June 1st, 2018) - ResearchAndMarkets.com

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.


Day 01 (8:30 AM - 4:30 PM)

  • Lecture 1: Overview of the drug development program and source of relevant submission documents
  • Lecture 2: Discussion of the roles and responsibilities for CTD preparation
  • Lecture 3: Review of the CTD format requirements
  • Lecture 4: Discussion on the successful transition from other formats to the CTD
  • Lecture 5: Placement of content into the CTD format; including less obvious items
  • Lecture 6: Review of different requirements across regions (US, EU, Canada)
  • Lecture 7: Implementing tools for the project management of CTD preparation and publishing

Day 02 (8:30 AM - 4:30 PM)

  • Lecture 8: Technical requirements for an eCTD submission
  • Lecture 9: Document naming requirements
  • Lecture 10: Building the folder structure
  • Lecture 11: Internal document requirements for the eCTD
  • Lecture 12: Performing "pre-publishing" work for each document
  • Lecture 13: Tools for tracking and managing eCTD content
  • Lecture 14: Performing quality checks on the eCTD
  • Lecture 15: Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

For more information about this conference visit https://www.researchandmarkets.com/research/fcw3n2/2day_workshop_by?w=4

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