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
View source version on businesswire.com: https://www.businesswire.com/news/home/20191213005313/en/
Contacts:
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
