Master of Science Regulatory Affairs for Drugs, Biologics,
and Medical Devices Online

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.
INT 6943 Integrative Experiential Learning 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

 

Attention: If you enrolled before Fall 2012, contact your student success specialist for your curriculum.

Quick Info

  • 45 Quarter Hours
  • $27,495.00 total tuition
    (Based on 2014-2015 tuition rate)
  • Full-time years to completion: 1 year
    Part-time years to completion: 2 years
©