eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada Webinar - ResearchAndMarkets.com

DUBLIN--()--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" webinar has been added to ResearchAndMarkets.com's offering.

This four day webinar series (each day 3 hrs) 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.

Date:

December 16-19, 2019

(10:00 AM to 1:00 PM PDT)

Viewing formats:

  • One dial in attendee (live)
  • Group - Max. 10 Attendees (live)
  • One user recorded version (unlimited viewing for 6 months)

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

Key Topics Covered:

Day 1 & 2: Review of CTD content and Structure

Day 1:

  • 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

Day 2:

  • 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

Day 3 & 4 : Review the eCTD. Setup and Submission Process

Day 3:

  • Technical requirements for an eCTD submission
  • Document naming requirements
  • Building the folder structure
  • Internal document requirements for the eCTD

Day 4:

  • Performing "pre-publishing" work for each document
  • Tools for tracking and managing eCTD content
  • Performing quality checks on the eCTD
  • Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

For more information about this webinar visit https://www.researchandmarkets.com/r/j9d73l

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