Introduction to Regulatory Affairs

This introductory course provides a comprehensive overview of the drug development process, from initial development through regulatory approval and commercialization.

The course emphasizes the role of regulatory agencies such as the U.S.

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonization (ICH).

Students will explore key aspects of regulatory compliance, including the roles and responsibilities of professionals across the pharmaceutical and biotechnology sectors, as well as the legal frameworks that govern the industry, such as the U.S.

Food, Drug, and Cosmetic Act, the Code of Federal Regulations (CFR), and applicable international regulations.