Program Overview

This course provides an overview of Regulatory Affairs (RA) in the biotechnology industry, covering the regulations and standards governing product development from inception to post-approval monitoring. It focuses on the U.S. and EU regulatory processes, including RA history, regulatory agencies, accessing RA information, and various regulations such as QSR, GLP, GCP, and GMP. The course aims to equip students with strategies for bringing products to market efficiently and safely.