CR 551S International Regulatory Affairs 3.0 Credits
Overview & analysis of the medical product regulatory processes within the world’s major markets, with an emphasis on pharmaceutical requirements. The key strategies required from preclinical product development & marketing approval - post-approval of medical products in the United States, European Union, & other markets will be compared & discussed. This course will cover the salient features of international regulatory affairs; the World Health Organization & international organizations; international law General Agreement on Tariffs and Trade & Trade-Related Aspects of Intellectual Property Rights & its impact on medical products; international regulatory agencies; & product development, marketing authorization, & post-approval requirements for pharmaceuticals, biologics,medical devices, & food & cosmetics.
Repeat Status: Not repeatable for credit