Regulatory Affairs for Biotechnology

This course introduces and reviews the role of Regulatory Affairs (RA) in the biotechnology industry. The RA environment embraces the regulations and standards governing product development, from its infancy through post-approval monitoring. In today's regulatory environment, products may be classified as biologics, drugs, medical devices or a combination of the former products. In most worldwide countries, each type of product is regulated by a different RA authority and often has its own distinct regulations. This course primarily focuses on the U.S. and the European Union (EU) regulatory processes (although other countries such as Canada and Japan are also briefly reviewed). Course topics include RA history, the various regulatory agencies, accessing RA information, drug submissions, biological submissions, Quality System Regulations (QSR), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and EU and FDA inspections. Instruction also includes strategies to get products to market quickly and in a safe and efficacious fashion.