Fundamentals of Global Regulatory Affairs.

Catalog description

This foundational pharmaceutical science course will provide an overview of regulatory affairs with a focus on global pharmaceutical product development. Students will learn about drug and biologics regulation in the US, EU, UK, Japan, and Australia. Students will also learn about the process for obtaining and maintaining global marketing approval along with tools and approaches used by regulatory professionals. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.