eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018 is a seminar that covers topics such as:
- 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
eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018 brings together:
- Quality Assurance
- Regulatory Affairs
- Project Management
- Pharmacovigilance
- Anyone responsible for providing content for the CTD
- Regulatory Operations
