This online course provides an in-depth view of how to fully and efficiently utilize interactions with regulators and inspectors, to successfully plan for clinical trials prior to establishing manufacturing setups - including important do's and don'ts of interactions with inspection teams and preparations for GMP standard examinations.
Learning objectives:
- Gain fundamental regulatory knowledge of the Canadian context for cell and gene therapies
- Be able to identify key Canadian regulations & policies relevant to various cell and gene therapies
- Develop your ability to plan Canadian regulatory interactions
Duration: approx. 1 hour