Regulatory Affairs

This course is designed to familiarize students with U.S. Food and Drug Administration (FDA) and international regulations regarding drug development, including textbook, on-line medical resources and data bases related to drug approval and regulation. Students will meet with representatives of various departments of pharmaceutical manufacturers and distributors to develop an understanding of their functions and responsibilities and to see how a regulatory affairs department supports various aspects of the company, including marketing, clinical research, customer interaction center and medical affairs.