Webinar Series: eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada - Webinar

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.

Areas Covered in the Webinar:

• Part 1 & 2: Review of CTD content and Structure
• Part 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
• Part 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
• Part 3 & 4 : Review the eCTD. Setup and Submission Process
• Part 3:
• Technical requirements for an eCTD submission
• Document naming requirements
• Building the folder structure
• Internal document requirements for the eCTD
• Part 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.)

Who Will Benefit:

• 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