Advancing Innovation: The Role of Regulatory Affairs

1 credits · Graduate Programs

Explores the importance of regulatory strategy and how regulatory decisions can impact the overall strategic direction of a business. Students will learn through real life examples and case studies, with a focus on biopharmaceuticals, medical devices, health tech and diagnostics/tools. An emphasis will be placed on Health Canada, the US Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare products Regulatory Agency (United Kingdom). Students will gain an understanding of the regulatory requirements needed for the development and commercialization of products, case studies, and group presentations. Prerequisite(s): Admission to the Master of Biomedical Technology program. Also known as: (formerly Medical Graduate Education 605)