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)

DUBLIN, April 12, 2018 /PRNewswire/ --

The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official " conference has been added to ResearchAndMarkets.com's offering.

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.

Agenda

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/tmzm32/2day_workshop_by?w=5

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SOURCE Research and Markets