Required Courses

BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6002Introduction to Regulatory Compliance and Practice2
RGA 6300Practical Applications in Global Regulatory Affairs4
RGA 6212Introduction to Safety Sciences4
RGA 6463Regulatory Strategy for Product Development and Life-Cycle Management4
Complete one of the following:5
Pharmaceutical and Medical Device Law: Topics and Cases
Legal Issues in International Food, Drug, and Medical Device Regulation

Concentrations

A concentration is not required.  The remaining required quarter hours for this program may be completed by selecting a combination of a concentration and electives or selecting any courses listed in the concentrations and electives. 

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required


Concentration in Biopharmaceutical Regulatory Affairs

RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
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

Concentration in Clinical Research Regulatory Affairs

BTC 6211Validation and Auditing of Clinical Trial Information4
BTC 6213Clinical Trial Design Optimization and Problem Solving4
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
Complete one of the following:4
Therapeutic Product Development: A Regulatory Overview
Medical Device Development: A Regulatory Overview
Managing International Clinical Trials

Concentration in Medical Device Regulatory Affairs 

RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
Complete one of the following:2-4
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

Concentration in Nonclinical Biomedical Product Regulation

RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6405Nonclinical Regulations in Biomedical Product Commercialization4
Choose one of the following:2
Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
Introduction to Food and Drug Administration (FDA) Medical Device Regulation

Concentration in Quality Assurance and Compliance

RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
RGA 6234Risk Management: Compliance and Processes4
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 one of the following:4
European Union Compliance Process and Regulatory Affairs
Fundamentals of CMC Regulations and Methods

Electives 

Experiential Project Preparation
Advanced Topics in Advertising and Promotion of Drugs and Medical Devices
Therapeutic Product Development in Canada