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Institute for Translational Medicine and Therapeutics
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Master of Regulatory Affairs
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48 MRA Curriculum

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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.

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The MRA curriculum is designed for working professionals. The courses are scheduled in the evenings, typically at 4:00PM or later.

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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.

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Degree Requirements

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Core Courses

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All students take 4 core courses.

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  • REG 5100 Introduction to Clinical and Translational Research (1 c.u.)
    • 4c
  • REG 6100 Fundamentals of FDA Regulation (1 c.u.)
    • 4e
  • REG 6120 Introduction to Drug Development (1 c.u.)
    • 42
  • REG 6190 Research Ethics (1 c.u.)
    • 7
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Concentration Course

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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.).

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  • Standard Concentration 6
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    • REG 6150 Post-Approval Maintenance of Drugs, Devices, and Biologics
      • 7
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  • Quality Assurance Concentration: Offers a particular focus on GLP and GMP-compliant management of product development and manufacturing. 6
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    • REG 6160 Quality Assurance
      • 7
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    • 70
  • Clinical Research Concentration: Offers a particular focus on GCP-compliant management of clinical trials. 6
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    • REG 6110 Clinical Trial Management
      • 7
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    • 7
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Electives

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  • 3 Approved Electives (3 c.u.)
    • 7
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Capstone

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  • REG 6400 Capstone I (1 c.u.)
    • 39
  • REG 6410 Capstone II (1 c.u.)
    • 7
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Study Plans

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Two-Year Study Plan

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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).

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Year 1 - Fall

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  • REG 5100 Intro Clinical Research
    • 40
  • REG 6120 Intro Drug Development
    • 7
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Year 1 - Spring

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  • REG 6400 Capstone I
    • 39
  • REG 6190 Research Ethics
    • 7
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Year 1 - Summer

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  • REG 6100 Fundamentals of FDA Regulations
    • 2d
  • Elective or Concentration Course 1
    • 7
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Year 2 - Fall

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  • Elective or Concentration Course 2
    • 2d
  • Elective or Concentration Course 3
    • 7
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Year 2 - Spring

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  • REG 6410 Capstone II
    • 2d
  • Elective or Concentration Course 4
    • 7
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Three-Year Study Plan

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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). 

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Year 1 - Fall

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  • REG 5100 Intro Clinical Research
    • 40
  • REG 6120 Intro Drug Development
    • 7
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Year 1 - Spring

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  • REG 6400 Capstone I
    • 39
  • REG 6190 Research Ethics
    • 7
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Year 1 - Summer: REG 6100 Fundamentals of FDA Regulation

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Year 2 - Fall: Elective or Concentration Course 1

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Year 2 - Spring: Elective or Concentration Course 2

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Year 2 - Summer: Elective or Concentration Course 3

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Year 3 - Fall: Elective or Concentration Course 4

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Year 3 - Spring: REG 6410 Capstone II

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Regulatory Affairs Courses

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For descriptions of REG courses, please see the University of Pennsylvania catalogue. 

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Visit the ITMAT Education Courses page for an up-to-date listing of which courses are offered each semester.

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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. 

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  • REG 6180 Introduction to Vaccine Development 
    • 31
  • REG 6210 Cell & Gene Therapy 
    • 4a
  • REG 6240 Applied Regulatory Processes of Vaccines and Biologics
    • 4c
  • REG 6250 Manufacturing Novel Therapies & Imaging Agents 
    • 33
  • REG 6260 Patent Law for Drug Development
    • 3c
  • LAWM 5360 Fundamentals of US Legal Research 
    • 6
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Classes that may not be offered online: 

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  • REG 6220 New Trends in Medicine & Vaccine Discovery
    • 3e
  • MTR 6200 Commercializing Translational Therapeutics
    • 66
  • HCMG 8990 Management & Economics of the Pharma, Biotech & Medical Device Industries
    • 31
  • PUBH 5020 Introduction to Epidemiology
    • 3d
  • LAW 5220 Compliance and Corporate Governance 
    • 33
  • LAW 5290 Navigating the Regulatory State
    • 3a
  • LAW 5300 Intro to Health Law & Policy 
    • 3f
  • LAW 9200 Pharmaceutical Regulation & Enforcement
    • 34
  • BMIN 5010 Intro to Biomedical Informatics
    • 35
  • BMIN 5020 Databases in Biomedical Research
    • 2c
  • BIOE 5520 Bioethics & the Law
    • 22
  • BIOE 5750 Health Policy
    • 6
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Please review Penn's catalogue for course descriptions. 

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Accreditation

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The University of Pennsylvania is accredited, but there is no separate accreditation for regulatory affairs programs.

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