This course will broadly cover fundamentals and preliminary requirements needed for successful cell therapy clinical trial applications (CTA). Upon completion, participants will be able to discuss and contribute to conversations around global clinical trial regulatory plans, identify the contents of a CTA and the basic differences between the Canadian, US, and EU regulatory activities surrounding clinical trials. Participants will subsequently gain confidence for approaching regulatory interactions for their own CTAs.
- Discuss / contribute to cell and gene therapy global clinical trial regulatory plans
- Identify basic differences between Canadian, US, and EU regulatory activities surrounding clinical trials
- Gain confidence for approaching regulatory interactions