The fundamentals and preliminary requirements behind a successful cell therapy Clinical Trial Application,
including where Canadian, US and EU expectations diverge.
Learning Objectives:
- Discuss / contribute to cell and gene therapy global clinical trial regulatory plans
- Identify the contents of a Clinical Trial Application and the basic differences between Canadian, US
and EU regulatory activities - Gain confidence in preparing for and navigating regulatory interactions for your own submissions
Modules:
- Introductory Remarks
- Fundamentals for Approaching the Regulators
- Optional Regulatory Interactions
- Canadian Clinical Trial Application Contents
- Planning for Clinical Trial Applications
- Common Questions and Challenges
EST. COMPLETION 1.5 HRS - E-Learning format