CLR 520 - Regulatory Affairs & Project Management

Credits: 3

In-depth study of regulations pertaining to biopharmaceutical and device development, including, but not limited study of INDs, NDAs, ANDAs, CANDAs, PLAs, CMC, submission processes, and financial/accounting (Sarbanes-Oxley) compliance. Studies the organization, responsibilities, and interactions between Regulatory Affairs and Project Management necessary to successfully manage pre-clinical and clinical research projects.

Click here for the Spring 2025 Class Schedule.