Required Courses (16 q.h.)

RGA 6200	Biologics Development: A QA/Regulatory Overview	4 q.h.
RGA 6201	New Drug Development: A QA/Regulatory Overview	4 q.h.
RGA 6202	Medical Device Development: A QA/Regulatory Overview	4 q.h.

Choose one of the following courses: 

RGA 6203	Food, Drug, and Medical Device Law: Topics and Cases	4 q.h.
RGA 6206	Practical Aspects of Regulatory Compliance	4 q.h.
RGA 6210	Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets	4 q.h.
RGA 6211	Combination Products and Convergence	4 q.h.
RGA 6212	Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad	4 q.h.
RGA 6214	Food and Drug Administration: Creation, Behavior, and Regulatory Culture	4 q.h.
RGA 6216	Medical, Social, and Financial Dimensions of Orphan Drugs	4 q.h.
RGA 6217	Biomedical Product Development: From Biotech to Boardroom to Market	4 q.h.
TCC 6370	Regulatory Writing: Medical Device Submissions	4 q.h.
TCC 6380	Regulatory Writing: New Drug Applications	4 q.h.

 

Total Quarter Hours: 16