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


The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career goals in the fields of regulatory affairs -- such as operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory compliance -- by focusing their education in one of six unique concentrations that span the entire discipline. 

Students choose one of the following concentrations:

Operational Regulatory Affairs Concentration


Purpose: Provide practical knowledge in strategizing and compiling regulatory filings in the U.S. and major markets (E.U. and Canada)


Required Courses (33 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A Regulatory Overview  4 q.h. 
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 5 q.h.
RGA 6370 Regulatory Writing: Medical Device Submissions 4 q.h.
RGA 6380 Regulatory Writing: New Drug Applications
4 q.h.
RGA 6300 Practical Applications in Biomedical Product Global Regulatory Affairs  4 q.h. 


Required Electives (12 q.h.)

Students must earn a minimum of 12 quarter hours by choosing at least one course from each category.

Regulatory and Clinical Operations
RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h.
RGA 6310 Regulatory Documentation Processes 4 q.h.
RGA 6212 Introduction to Safety Sciences 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamentals 4 q.h. 

 

Regulatory Perspective: Product Development, Business and Strategy
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6205 Emerging Trends and Issues in the Medical Device Industry  4 q.h. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products  4 q.h. 
RGA 6211  Combination Products and Convergence  4 q.h. 
RGA 6112  Biomedical Intellectual Property Management: Patents  4 q.h. 
COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
4 q.h.
INT 6943 Integrative Experiential Learning
  • Students may also take  RGA 6920  (1 q.h.) to meet the 4 q.h. elective course requirement
3 q.h.

 

International
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 q.h.
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h.
RGA 6222 European Medical Device Regulations 4 q.h.
RGA 6224 Regulation of Biomedical Product Commercialization by Health Canada 4 q.h. 
RGA 6223 Introduction to Canadian, 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. 

 

Strategic Regulatory Affairs Concentration

Purpose:  Provide philosophy and methodologies to support life science companies’ business objectives with regulatory strategy and support it with clinical strategy. Provide methodologies to align regulatory and clinical strategies to product approvals, health economics, reimbursement, etc. 

Special Admission Requirement: The content of this concentration is designed for seasoned regulatory professionals and expects basic knowledge of the field. As such, successful applicants should have at least 3-4 years of direct experience in a regulatory affairs-related position.

Required Courses (25 q.h.)

RGA 6201 New Drug Development: A Regulatory Overview 4 q.h.
RGA 6202 Medical Device Development: A Regulatory Overview 4 q.h.
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6203  Food, Drug, and Medical Device Law: Topics and Cases  5 q.h. 
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.
RGA 6300 Practical Applications in Biomedical Product Global Regulatory Affairs 4 q.h. 


Required Electives (20 q.h.)

Students must earn a minimum of 20 quarter hours by choosing at least one course from each category.

Regulatory and Clinical Operations
RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h.
RGA 6212 Introduction to Safety Sciences 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information  4 q.h. 
BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamental to Clinical Trials 4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6216  Medical, Social, and Financial Dimensions of Orphan Drugs  4 q.h. 
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6112 Biomedical Intellectual Property Management: Patents 4 q.h. 
RGA 6205  Emerging Trends and Issues in the Medical Device Industry  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products  4 q.h. 
RGA 6250  Financing and Reimbursement in Biomedical Product Development  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. 
COP 6940  Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
4 q.h. 
INT 6943  Integrative Experiential Learning
  • Students may also take  RGA 6920  (1 q.h.) to meet the 4 q.h. elective course requirement
3 q.h. 

 

International
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 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 Introduction to Canadian, Asian, and Latin American Regulatory Affairs 4 q.h.
RGA 6224 Regulation of Biomedical Product Commercialization by Health Canada 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. 

 

   Clinical Research Regulatory Affairs Concentration 


Purpose:  Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support product development.

Required Courses (29 q.h.)

RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A Regulatory Overview  4 q.h. 
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 5 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamental to Clinical Trials 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving  4 q.h. 
RGA 6300 Practical Applications in Biomedical Product Global Regulatory Affairs  4 q.h. 

 

Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations
RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information  4 q.h. 
RGA 6212 Introduction to Safety Sciences 4 q.h.
RGA 6230 Clinical Laboratory Management in Clinical Trials 4 q.h. 
RGA 6310 Regulatory Documentation Processes 4 q.h. 
RGA 6280 Advanced Writing on International Biomedical Topics  4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260  The Business of Medicine and Biotechnology 4 q.h. 
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market  4 q.h. 
RGA 6215 Project Management in Early Drug Discovery and Development 4 q.h. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products 4 q.h. 
RGA 6250  Financing and Reimbursement in Biomedical Product Development  4 q.h. 
RGA 6211 Combination Products and Convergence 4 q.h. 
COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
4 q.h. 
INT 6943  Integrative Experiential Learning
  • Students may also take  RGA 6920  (1 q.h.) to meet the 4 q.h. elective course requirement
3 q.h. 

 

International
RGA 6228 Managing International Clinical Trials 4 q.h. 
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 q.h.
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h. 
RGA 6223  Introduction to Canadian, Asian, and Latin American Regulatory Affairs  4 q.h. 
RGA 6224 Regulation of Biomedical Product Commercialization by Health Canada  4 q.h. 

 

   International Regulatory Affairs Concentration


Purpose:  Provide practical knowledge on the process of international registrations of life science products, methods of international regulatory and clinical filings.

Required Courses (29 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A Regulatory Overview  4 q.h. 
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6220
Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 q.h.
RGA 6223
Introduction to Canadian, Asian, and Latin American Regulatory Affairs 4 q.h.
RGA 6300 Practical Applications in Biomedical Product Global Regulatory Affairs  4 q.h. 


Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h. 
RGA 6212 Introduction to Safety Sciences 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h.
RGA 6370 Regulatory Writing: Medical Device Submissions 4 q.h. 
RGA 6380 Regulatory Writing: New Drug Applications  4 q.h. 
RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 5 q.h.
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6205 Emerging Trends and Issues in the Medical Device Industry 4 q.h. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products 4 q.h. 
RGA 6211 Combination Products and Convergence 4 q.h. 
COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
4 q.h. 
INT 6943  Integrative Experiential Learning
  • Students may also take  RGA 6920  (1 q.h.) to meet the 4 q.h. elective course requirement
3 q.h. 

  

International
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h.
RGA 6222 European Medical Device Regulations 4 q.h.
RGA 6224 Regulation of Biomedical Product Commercialization by Health Canada 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 6229  Biomedical Product Regulatory Affairs in Emerging Markets: RUssia and Kazakhstan  4 q.h. 
RGA 6211 Combination Products and Convergence 4 q.h.

    

Regulatory Compliance Concentration


Purpose: Provide in-depth practical knowledge of regulatory compliance of life science manufacturing (including CMC – Chemistry, Manufacturing, & Controls) and Quality System practices.


Required Courses (25 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A 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 5 q.h.
RGA 6300 Practical Applications in Biomedical Product Global Regulatory Affairs 4 q.h.


Required Electives (20 q.h.)

Students must earn a minimum of 20 quarter hours by choosing at least one course from each elective category:

Regulatory and Clinical Operations
RGA 6212 Introduction to Safety Sciences 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h. 
RGA 6230 Clinical Laboratory Management in Clinical Trials 4 q.h.
RGA 6234 Drug and Device Supplier Risk Management: Compliance and Processes 4 q.h. 
RGA 6280 Advanced Writing on International Biomedical Topics  4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6210 Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products 4 q.h. 
RGA 6205  Emerging Trends and Issues in the Medical Device Industry  4 q.h. 
RGA 6211 Combination Products and Convergence 4 q.h. 
COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
4 q.h. 
INT 6943  Integrative Experiential Learning
  • Students may also take  RGA 6920  (1 q.h.) to meet the 4 q.h. elective course requirement
3 q.h. 

International
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h.
RGA 6222 European Medical Device Regulations 4 q.h.
RGA 6223 Introduction to Canadian, Asian, and Latin American Regulatory Affairs 4 q.h.
RGA 6224 Regulation of Biomedical Product Commercialization by Health Canada 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. 

 

General Regulatory Affairs Concentration


Purpose: Provide general knowledge of regulatory profession.

Required Courses (29 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamentals 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview 4 q.h. 
RGA 6202  Medical Device Development: A 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. 
RGA 6300 Practical Applications in Biomedical Product Global Regulatory Affairs  4 q.h. 

 

Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category:

Regulatory and Clinical Operations
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving  4 q.h. 
RGA 6212 Introduction to Safety Sciences 4 q.h.
RGA 6230 Clinical Laboratory Management in Clinical Trials 4 q.h.
RGA 6280 Advanced Writing on International Biomedical Topics
4 q.h.
RGA 6310 Regulatory Documentation Processes  4 q.h.
RGA 6370 Regulatory Writing: Medical Device Submissions 4 q.h.
RGA 6380 Regulatory Writing: New Drug Applications 4 q.h.
RGA 6233  Application of Quality System Regulation in Medical Device Design and Manufacturing 4 q.h.
RGA 6234 Drug and Device Supplier Risk Management: Compliance and Processes 4 q.h.

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260 The Business of Medicine and Biotechnology 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 6219 Advertising and Promotion of Drugs and Medical Device Products 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 6245  Regulation of Generic Pharmaceutical and Biosimilar Products  4 q.h. 
RGA 6250 Financing and Reimbursement in Biomedical Product Development  4 q.h. 
COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
4 q.h. 
INT 6943  Integrative Experiential Learning
  • Students may also take  RGA 6920  (1 q.h.) to meet the 4 q.h. elective course requirement
3 q.h. 

 

International
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 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 Introduction to Canadian, Asian, and Latin American Regulatory Affairs  4 q.h.
RGA 6224 Regulation of Biomedical Product Commercialization by Health Canada  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.

 


Required minimum credit hours: 45 q.h.

Quick Info

  • 45 Quarter Hours
  • $29,880.00 total tuition
    (Based on 2016-2017 tuition rate)
  • Full-time years to completion: 1 year
    Part-time years to completion: 2 years
©