eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018

Topics

• Roles and responsibilities for CTD preparation
• Drug development program and source of relevant submission documents
• Successful transition from other formats to the CTD
• 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

• Quality Assurance
• Regulatory Affairs
• Project Management
• Pharmacovigilance
• Anyone responsible for providing content for the CTD
• Regulatory Operations