CLRE 6700 - Global Regulation of Medical Products

Prerequisite: CLRE 6100. This course is designed to provide a working knowledge of regulatory affairs in the pharmaceutical industry. Emphasis will be on the U.S. pharmaceutical development, although topics will include development outside the U.S. and the development of biologics, over-the-counter (OTC) drugs and devices. Legal issues related to clinical research and regulatory affairs will be explored as well as Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). 3 credits.