Introduction to Regulatory Affairs

This course was developed by the UBC Faculty of Medicine, and the UBC Academy of Translational Medicine’s Regulatory Advisory Council which offers an introductory overview to the Canadian and global regulatory affairs landscape. Recipients of this credential are able to: 1. Identify the key stakeholders and agencies involved in Canadian and global regulatory systems 2. Understand the basic tools for evaluating the safety and efficacy of drugs and health products 3. Describe clinical trials and identify their associated regulatory requirements 4. Describe the process pathway for medical devices.