Preparing Compliant eCTD Submissions: Are you prepared for the upcoming FDA mandate on e-submissions 2016
17 Aug 2016
Webinar
Description
Topics
Discussion of the roles and responsibilities for CTD preparation
Overview of the drug development program and source of relevant submission documents
Discussion on the successful transition from other formats to the CTD
Review of the CTD format requirements
Technical requirements for an eCTD submission
Implementing tools for the project management of CTD preparation and publishing
Building the folder structure
Document naming requirements
Tools for tracking and managing eCTD content
Performing "pre-publishing" work for each document
Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
Performing quality checks on the eCTD
Who should Attend
Attendees from:
Quality Assurance
Regulatory Affairs
Project Management
Pharmacovigilance
Anyone responsible for providing content for the CTD
Regulatory Operations
Past Events
Preparing Compliant eCTD Submissions: Are you prepared for the upcoming FDA mandate on e-submissions 2016 - 17 Aug 2016, Webinar (61327)
Important
Please, check "Preparing Compliant eCTD Submissions: Are you prepared for the upcoming FDA mandate on e-submissions" official website for possible changes, before making any traveling arrangements
