MS in Regulatory Affairs

Curriculum

REQUIRED COURSES (Essential Topics)
RGA 6100	Introduction to Drug and Medical Device Regulation	4 q.h.
RGA 6203	Food, Drug, and Medical Device Law: Topics and Cases	4 q.h.
BTC 6210	Human Experimentation: Methodological Issues Fundamental to Clinical Trials	4 q.h.
RGA 6201	New Drug Development: A QA Regulatory Overview	4 q.h.
RGA 6200	Biologics 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 (Business and Law):
BTC 6260	The Business of Medicine and Biotechnology	4 q.h.
RGA 6110	Understanding the Health Care Landscape	4 q.h.
RGA 6112	Biomedical Intellectual Property Management: Patents, Trademarks, Copyrights, Trade Secrets, and Technology Licensing	4 q.h.
RGA 6214	Food and Drug Administration: Creation, Behavior, and Regulatory Culture	4 q.h.
RGA 6220	Global Biotechnology Product Registration: E.U., U.S., and Japan	4 q.h.
RGA 6221	European Union Compliance Process and Regulatory Affairs	4 q.h.
HMG 6170	Health Law, Politics, and Policy	3 q.h.
RGA 6218	Regulatory Affairs in an Entreprenurial Environment	4 q.h.
RGA 6217	Biomedical Product Development: From Biotech to Boardroom to Market	4 q.h.

Choose one of the following (Safety and Surveillance):
BTC 6211	Validation and Auditing of Clinical Trial Information	4 q.h.
RGA 6206	Practical Aspects of Regulatory Compliance	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.
TCC 6370	Regulatory Writing: Medical Device Submissions	4 q.h.
TCC 6380	Regulatory Writing: New Drug Applications	4 q.h.
TCC 6310	Regulatory Documentation Processes	4 q.h.
RGA 6219	Advertising and Promotion of Drugs and Devices	4 q.h.

Choose one of the following (Development & Marketing):		4 q.h.
BTC 6213	Clinical Trial Design Optimization and Problem Solving	4 q.h.
RGA 6205	Emerging Trends and Issues in the Medical Devices Industry	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 6215	Project Management in Early Drug Discovery and Development	4 q.h.
RGA 6216	Medical, Social, and Financial Dimensions of Orphan Drugs	4 q.h.
PMC 6212	Clinical Drug Development Data Analysis: Concepts and Applications	4 q.h.
RGA 6228	Managing International Clinical Trials	4 q.h.
RGA 6280	Advanced Writing on International Biomedical Topics	4 q.h.

One Course Open Elective -- Some Suggested Topics:
RGA 6213	Safety Sciences 2: Safety Surveillance, Pharmacoepidemiology, and Risk Management in the U.S. and Abroad	4 q.h.
RGA 6222	Global Awareness: European Medical Device Regulations	4 q.h.
RGA 6223	Global Awareness: Introduction to Canadian, Asian, and Latin American Regulatory Affairs	4 q.h.
RGA 6225	Global Awareness: Japan Medical Device Regulations and Registrations	4 q.h.
RGA 6226	Canadian and Australian Medical Device Regulations	4 q.h.
RGA 6227	Global Awareness: Emerging Medical Device Markets	4 q.h.

TOTAL QUARTER HOURS 40 q.h.