Complete all courses and requirements listed below unless otherwise indicated.
Required Courses
| Code | Title | Hours |
|---|---|---|
| BTC 6210 | Human Experimentation: Methodological Issues Fundamentals | 4 |
| RGA 6002 | Introduction to Regulatory Compliance and Practice | 2 |
| RGA 6203 | Pharmaceutical and Medical Device Law: Topics and Cases | 5 |
| or RGA 6204 | Legal Issues in International Food, Drug, and Medical Device Regulation | |
| RGA 6212 | Introduction to Safety Sciences | 4 |
| RGA 6463 | Regulatory Strategy for Product Development and Life-Cycle Management | 4 |
Capstone
| Code | Title | Hours |
|---|---|---|
| RGA 6300 | Practical Applications in Global Regulatory Affairs | 4 |
The remaining quarter hours may be completed by selecting a combination of a concentration and additional electives or selecting any courses listed in the concentrations and electives lists.
Concentrations
- Biopharmaceutical Regulatory Affairs
- Clinical Research Regulatory Affairs
- Medical Device Regulatory Affairs
- Nonclinical Biomedical Product Regulation
- Quality Assurance Compliance
Program Credit/GPA Requirements
45 total quarter hours required
Minimum 3.000 GPA required
Elective Courses
| Code | Title | Hours |
|---|---|---|
| General Electives | ||
COP 6940 | ||
EDU 6184 | ||
| Integrative Experiential Learning | ||
| Emerging Trends and Issues in the Medical Device Industry | ||
| Strategic Planning and Project Management for Regulatory Affairs | ||
| Project Management in Early Drug Discovery and Development | ||
| Biomedical Product Development: From Biotech to Boardroom to Market | ||
| Advanced Topics in Advertising and Promotion of Drugs and Medical Devices | ||
RGA 6255 | ||
| Cybersecurity and Regulation of Digital Health Technologies by the FDA | ||
| Regulatory Affairs of Food | ||
| Global Economics of Food and Agriculture | ||
| Sustainable Development | ||
| Global Corporate Social Responsibility | ||
RFA 6220 | ||
| International Regulatory Affairs | ||
| European Union Compliance Process and Regulatory Affairs | ||
| European Medical Device Regulations | ||
| Introduction to Australian, Asian, and Latin American Regulatory Affairs | ||
| Regulation of Biomedical Product Commercialization by Health Canada | ||
| Managing International Clinical Trials | ||
| Managing International Clinical Trials | ||
| Medical Device Product Development in Canada | ||
| Therapeutic Product Development in Canada | ||
Concentrations
Biopharmaceutical Regulatory Affairs
| Code | Title | Hours |
|---|---|---|
| RGA 6000 | Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | 2 |
| RGA 6101 | Therapeutic Product Development: A Regulatory Overview | 4 |
| RGA 6207 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 4 |
| RGA 6380 | Advanced Regulatory Writing: New Drug Applications | 4 |
| Complete one of the following: | 4 | |
| Biomedical Product Development: From Biotech to Boardroom to Market | ||
| Emerging Product Categories in the Regulation of Drugs and Biologics | ||
Clinical Research Regulatory Affairs
| Code | Title | Hours |
|---|---|---|
| BTC 6211 | Validation and Auditing of Clinical Trial Information | 4 |
| BTC 6213 | Clinical Trial Design Optimization and Problem Solving | 4 |
| RGA 6101 | Therapeutic Product Development: A Regulatory Overview | 4 |
| or RGA 6202 | Medical Device Development: A Regulatory Overview | |
| Complete one of the following: | 4 | |
| Biomedical Product Development: From Biotech to Boardroom to Market | ||
| Managing International Clinical Trials | ||
Medical Device Regulatory Affairs
| Code | Title | Hours |
|---|---|---|
| RGA 6001 | Introduction to Food and Drug Administration (FDA) Medical Device Regulation | 2 |
| RGA 6202 | Medical Device Development: A Regulatory Overview | 4 |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| Complete one of the following: | 6 | |
| Emerging Trends and Issues in the Medical Device Industry | ||
| European Medical Device Regulations | ||
| Medical Device Product Development in Canada | ||
| Product Development and Process Validation | ||
| Advanced Regulatory Writing: Medical Device Submissions | ||
Nonclinical Biomedical Product Regulation
| Code | Title | Hours |
|---|---|---|
| RGA 6207 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 4 |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| RGA 6405 | Nonclinical Regulations in Biomedical Product Commercialization | 4 |
| RGA 6420 | Global IVD Regulations and Submissions | 4 |
Quality Assurance Compliance
| Code | Title | Hours |
|---|---|---|
| Complete one of the following: | 2 | |
| Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | ||
| Introduction to Food and Drug Administration (FDA) Medical Device Regulation | ||
| Cybersecurity and Regulation of Digital Health Technologies by the FDA | ||
| Complete the following: | ||
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| RGA 6234 | Risk Management: Compliance and Processes | 4 |
| RGA 6275 | Product Development and Process Validation | 2 |
| Choose from the following to reach 16 quarter hours: | 4 | |
| European Union Compliance Process and Regulatory Affairs | ||
| Fundamentals of CMC Regulations and Methods | ||
RFA 6220 | ||