eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada is a course that covers topics such as:
- Ground Rules for Writing, Formatting and Updating Content
- Introduction to eCTD
- CMC Information Presentation
- Summaries in an NDA
- Putting the Whole Submission Together
- Bulk Data from Non-Clinical and Clinical Studies
- Introduction to the FDA’s ESG
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada brings together:
- 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