PHARM 7568 - Regulatory Affairs and Intellectual Property in Biopharmaceutical Sciences

This course introduces students to regulatory principles (regulatory affairs, regulatory sciences), and intellectual property. This content is anticipated as useful to those considering a career in pharmaceutical or biotechnology industry, academia, or government. This course will primarily focus on US laws and regulations, (FDA, PHS, USPTO); however, as pharmaceutical and biological therapies are a multi-national, global industry, there will be a brief introduction to international regulatory affairs (Health Canada, European Medicines Agency [EMA], PMDA [Japan]) and international intellectual property (Paris Convention, and WIPO).