Introduction to Regulatory Affairs - Medical Products

4 Credits.

This course introduces students to the regulatory frameworks governing the development, approval, and post-market surveillance of medical products including drugs, biologics, and medical devices. Students will explore the historical context of pharmaceutical regulation, the structure of the FDA, and the processes associated with product development. By examining regulatory submissions, case studies, and enforcement actions, students will gain the foundational knowledge and practical skills required for careers in regulatory affairs.