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Course Description

Before drugs are available to the public, a rigorous regulatory process must be completed to satisfy factors like public safety, product efficacy, and ethics of use. This course provides an overview of the Canadian and U.S. drug regulatory process including guidelines for preclinical and clinical research, data management, and research ethics. It will rely heavily on specific case studies of drug approvals, with emphasis on critical evaluation of scientific data relevant to the regulatory process of each case.

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