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This capstone course will help you examine current, often complex, Regulatory Affairs issues impacting regulated biopharmaceutical industry. Presented by leading professionals with broad industry and FDA experience, this class will provide you with the opportunity to learn about and examine critical development decisions and practices at leading companies. A final project is required, where you will develop and present analysis of a significant RA topic to a panel of instructors and peers.

Note: Prerequisite: Regulatory Requirements for Drugs and Biologics

Course Number: BIOL-40110
Credit: 3.00 unit(s)