Regulation of Drugs and Biologics


Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course will help you understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Through lectures, case studies, and hands-on exercises, you'll gain knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, post-marketing requirements, the impact of regulatory differences between U.S. and other countries, and how regulatory approval processes affect corporate strategy.

Prerequisites :


Offering code Offering title
BTEC.X401 Drug Development Process