Health Care Legislation, Regulation and Guidelines

Course Code: REGA 5020

Academic Year: 2019-2020

This course focuses on Canadian legislation and regulations applicable to bringing therapeutic products to the Canadian market. It complements other courses within the Regulatory Affairs Program to ensure students gain the respective background information, regulatory framework and necessary resources to understand how these products are regulated in Canada and how regulatory affairs professionals can help organizations navigate through regulatory obstacles. The Food and Drugs Act, relevant regulations, policies, guidance documents as well as important initiatives with respect to pharmaceuticals, biologics, natural health products and various other therapeutic products are examined and discussed. The course also includes discussions on how regulatory affairs professionals add value to various organizations and what their opportunities are within the industry.