Attention students enrolled before fall 2012: download your curriculum here.

Required Courses (25 q.h.)* 

RGA 6100	Introduction to Drug and Medical Device Regulation	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 6202	Medical Device Development: A QA Regulatory Overview	4 q.h.
RGA 6200	Biologics Development: A QA Regulatory Overview	4 q.h.
RGA 6203	Food, Drug, and Medical Device Law: Topics and Cases (This course should be taken as the final required course.)	5 q.h.

*Please note: completion of RGA 6280: Advanced Writing on International Biomedical Topics may be required of students as a condition for their continued enrollment in this program.

Choose one of the following Safety and Surveillance courses (4 q.h.)

BTC 6211	Validation and Auditing of Clinical Trial Information	4 q.h.
RGA 6212	Safety Sciences 1: Introduction to Safety and Surveillance	4 q.h.
RGA 6213	Safety Sciences 2: Safety Surveillance, Pharmacoepidemiology, Risk	4 q.h.
RGA 6230	Clinical Laboratory Management in Clinical Trials	4 q.h.
RGA 6280	Advanced Writing on International Biomedical Topics Please note: completion of this course may be required of students as a condition for their continued enrollment in this program.	4 q.h.
TCC 6310	Regulatory Documentation Processes	4 q.h.
TCC 6370	Regulatory Writing: Medical Device Submissions	4 q.h.
TCC 6380	Regulatory Writing: New Drug Applications	4 q.h.
RGA6233	Application of Quality System Regulation in Medical Device Design and Manufacturing	4 q.h.
RGA6234	Drug and Device Supplier Risk Management Compliance and Processes	4 q.h.

Choose one of the following Business and Law courses (4 q.h.)

BTC 6260	The Business of Medicine and Biotechnology	4 q.h.
RGA 6110	Understanding the Health-Care Landscape	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.
RGA 6218	Regulatory Affairs in an Entrepreneurial Environment	4 q.h.
RGA 6219	Advertising and Promotion of Drugs and Medical Device Products	4 q.h.
RGA 6235	Emerging Product Categories in the Regulation of Drugs and Biologics	4 q.h.

Choose from one of the following Development and Strategy courses (4 q.h.)

BTC 6213	Clinical Trial Design Optimization and Problem Solving	4 q.h.
PMC 6212	Clinical Drug Development Data Analysis: Concepts	4 q.h.
RGA 6112	Biomedical Intellectual Property Management: Patents	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	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 6245	Regulation of Generic Pharmaceutical and Biosimilar Products	4 q.h.
RGA6250	Financing and Reimbursement in Biomedical Product Development	4 q.h.

Choose from one of the following International courses (4 q.h.)

RGA 6220	Global Biotechnology Product Registration: E.U., U.S. Product Regulation	4 q.h.
RGA 6221	European Union Compliance Process and Regulatory Affairs	4 q.h.
RGA 6222	European Medical Device Regulations	4 q.h.
RGA 6223	Global Awareness: Canada, Asian, and Latin American Regulatory Affairs	4 q.h.
RGA 6225	Japanese Medical Device Regulations and Registration	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.
RGA 6228	Managing International Clinical Trials	4 q.h.
RGA 6240	The Evolving Indian Regulatory Landscape	4 q.h.

Open Electives (4 q.h.) - Some Suggested Topics:

COP 6940	Personal and Career Development Enrollment into this is course requires participation in the cooperative education program (subject to availability) Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement Effective spring 2012, all students in this program are required to complete both RGA 6100 and BTC 6210 before enrolling in COP 6940	3 q.h.
RGA 6206	Practical Aspects of Regulatory Compliance	4 q.h.
	Or one course from any other category	4 q.h.

Total Quarter Hours: 45