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
2 Year Study Plan
All students are required to complete the 4 core courses and Capstone I in year 1.
Year 1
Fall
REG 5100 Intro Clinical Research
REG 6120 Intro Drug Development
Spring
REG 6400 Capstone I
REG 6190 Research Ethics
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
Spring
REG 6410 Capstone II
Elective or Concentration Course 4
All students are required to complete the 4 core courses and Capstone I in year 1.
Students then complete their electives and capstone project over a two year period, completing the degree in 3 years.
3 Year Study Plan:
Fall
Spring
Summer
Year 1
REG 5100 Intro Clinical Research
REG 6120 Intro Drug Development
REG 6400 Capstone I
REG 6190 Research Ethics
REG 6100 Fundamentals of FDA Regulations
Year 2
Elective or Concentration Course 1
Elective or Concentration Course 2
Elective or Concentration Course 3
Year 3
Elective or Concentration Course 4
REG 6410 Capstone II
The Master of Regulatory Affairs and Penn Law have partnered together to offer the MRA-ML dual degree. The purpose of this dual degree is to expand your knowledge of both regulatory and legal affairs as well as highlight the connection between these two fields. Upon completion of the dual degree, you should have a deeper understanding of the intersections between these two fields.
Dual Degree Curriculum
Students who elect to pursue the MRA-ML dual degree will be required to complete a select number of courses from the MRA and LAW programs. The curriculum is designed to provide knowledge of both legal and regulatory affairs. Students may take 3 LAW courses to replace REG 6190 Research Ethics and 2 electives.
While the MRA program is an online program, many courses in the ML program will be in person. Students who are interested in pursuing the MRA-ML dual degree will be required to attend in-person law classes.
MRA Courses
7 MRA courses based on your selected concentration (see above). REG 6190 and 2 electives are replaced by ML courses.
REG 5100 Intro to Clinical and Translational Research (required)
REG 6120 Intro to Drug Development (required)
REG 6100 Fundamentals of FDA Regulation (required; replaces 1 ML elective)
REG 6400 Capstone I (required)
REG 6410 Capstone II (required)
REG 6150 Post-approvals Maintenance, 6160 Quality Assurance, or 6110 Clinical Study Management depending on concentration
REG 6260 Patent Law for Drug Development (replaces 1 ML elective)
LAW Courses
6 ML courses. 2 MRA courses account for the final 2 CUs (REG 6100 and either REG 6260 or REG 6150).
LAW 5110 US Law & Legal Methods (required, replaces 1 MRA elective)
LAW 5280 General Business Law (required; cannot count toward MRA)
LAW 5290 Navigating the Regulatory State (required; replaces 1 MRA elective)
LAW 5300 Health Law & Policy (foundational course) or LAWM 5510 Healthcare Compliance, Ethics, and Governance (Replaces REG 6190)
Visit the ITMAT Education Courses page for an up-to-date listing of which courses are offered each semester.
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.
REG 6180 Introduction to Vaccine Development
REG 6210 Cell & Gene Therapy
REG 6240 Applied Regulatory Processes of Vaccines and Biologics
