The objective of the Master of Regulatory Affairs (MRA) degree program is to produce a cadre of highly trained and sophisticated practice professionals adept in the skills necessary to maximize compliance and minimize risk in the development of FDA regulated products. Students will learn both the foundation and application of science-based clinical investigation and the corresponding regulation. The program is designed to meet these objectives through didactic course work and an experiential capstone project.
For more information: https://www.itmat.upenn.edu/education-and-training/mra-overview/
Curriculum
Students must complete 10 course units and achieve a B- or higher for all course work counted toward the degree. The MRA program is a fully online program.
Course List | Code | Title | Course Units |
| REG 5100 | Introduction to Clinical and Translational Research | 1 |
| REG 6100 | Fundamentals of FDA Regulation | 1 |
| REG 6120 | Introduction to Drug Development | 1 |
| REG 6190 | Research Ethics in Regulatory Affairs | 1 |
| REG 6400 | Capstone I | 1 |
| REG 6410 | Capstone II | 1 |
| 3 |
| 1 |
| Total Course Units | 10 |
Concentrations
General
Course List | Code | Title | Course Units |
| REG 6150 | Post-Approval Maintenance of Drugs, Biologics, and Devices | 1 |
| Total Course Units | 1 |
Clinical Research
Course List | Code | Title | Course Units |
| REG 6110 | Clinical Trial Management | 1 |
| Total Course Units | 1 |
Quality Assurance
Course List | Code | Title | Course Units |
| REG 6160 | Quality Assurance | 1 |
| Total Course Units | 1 |
The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2024 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.