PHARM7568

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).

Prerequisites: Current P3 Doctor of Pharmacy Student OR Graduate student in a PhD program in the College of Pharmacy
OR Graduate student in the Biological Chemistry/Molecular Biology (BC/MB) PhD program.

Spring