Two Day Workshop: eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada - San Francisco, CA, United States - November 14-15, 2019 - ResearchAndMarkets.com

DUBLIN--()--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" 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.

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.

Who Should Attend:

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Medical and Technical writers
  • Professionals preparing IND, DMFs, NDAs and other submissions
  • IT Professionals
  • Anyone responsible for providing content for the CTD

Agenda:

Day 1

  • Registration Process - (8:30 am till 8:45 am)
  • 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 2

  • 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/r/v168po

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900