MRA Curriculum
The goal of the MRA curriculum is to provide a broad understanding of the FDA-regulated product lifecycle. The core courses focus on research and development, clinical research, FDA submissions and product registrations, manufacturing, labeling, advertising and post-approval maintenance activities. Course instructors bring expertise from academic medical centers, private industry, and the FDA. This prepares students to pursue careers in clinical research, regulatory or quality assurance sectors.
The MRA curriculum is designed for working professionals. The courses are scheduled in the evenings, typically at 4:00PM or later.
The MRA degree requires 10 credit units including coursework and a capstone. Students may choose to complete the degree in 2 or 3 years. Students may request an extension beyond 3 years for extenuating circumstances; a program fee may apply.
Degree Requirements
Core Courses
All students take 4 core courses.
- REG 5100 Introduction to Clinical and Translational Research (1 c.u.)
- REG 6100 Fundamentals of FDA Regulation (1 c.u.)
- REG 6120 Introduction to Drug Development (1 c.u.)
- REG 6190 Research Ethics (1 c.u.)
Concentration Course
You may choose to take the standard curriculum or elect a concentration to further specialize your training. Based on your choice, you would enroll in 1 concentration course (1 c.u.).
- Standard Concentration
- REG 6150 Post-Approval Maintenance of Drugs, Devices, and Biologics
- Quality Assurance Concentration: Offers a particular focus on GLP and GMP-compliant management of product development and manufacturing.
- REG 6160 Quality Assurance
- Clinical Research Concentration: Offers a particular focus on GCP-compliant management of clinical trials.
- REG 6110 Clinical Trial Management
Electives
- 3 Approved Electives (3 c.u.)
Capstone
- REG 6400 Capstone I (1 c.u.)
- REG 6410 Capstone II (1 c.u.)
Study Plans
Two-Year Study Plan
All students are required to complete the 4 core courses and Capstone I in year 1. MRA is a total of 10 course units (C.U.s).
Year 1 - Fall
- REG 5100 Intro Clinical Research
- REG 6120 Intro Drug Development
Year 1 - Spring
- REG 6400 Capstone I
- REG 6190 Research Ethics
Year 1 - Summer
- REG 6100 Fundamentals of FDA Regulations
- Elective or Concentration Course 1
Year 2 - Fall
- Elective or Concentration Course 2
- Elective or Concentration Course 3
Year 2 - Spring
- REG 6410 Capstone II
- Elective or Concentration Course 4
Three-Year Study Plan
All students are required to complete the 4 core courses and Capstone I in year 1. MRA is a total of 10 course units (C.U.s).
Year 1 - Fall
- REG 5100 Intro Clinical Research
- REG 6120 Intro Drug Development
Year 1 - Spring
- REG 6400 Capstone I
- REG 6190 Research Ethics
Year 1 - Summer: REG 6100 Fundamentals of FDA Regulation
Year 2 - Fall: Elective or Concentration Course 1
Year 2 - Spring: Elective or Concentration Course 2
Year 2 - Summer: Elective or Concentration Course 3
Year 3 - Fall: Elective or Concentration Course 4
Year 3 - Spring: REG 6410 Capstone II
Regulatory Affairs Courses
In addition to the courses listed on this page, MRA students may take additional REG courses as electives or courses outside the department. Some courses may be offered on-site at Penn rather than online.
Accreditation
The University of Pennsylvania is accredited, but there is no separate accreditation for regulatory affairs programs.