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. This allows students to pursue careers in clinical research, regulatory or quality assurance sectors.
The MRA curriculum is designed for working professionals, and it involves a variety of experts from UPenn, the Children's Hospital of Philadelphia (CHOP), private industry, and the FDA. We encourage students to continue their full-time job and take two courses each term toward the MRA degree. 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.
You may choose to take the standard MRA curriculum or elect a concentration in clinical research or quality assurance to further specialize your training. The core courses vary between each concentration.
Concentrations
The MRA curriculum is designed to provide a broad understanding of the FDA-regulated product lifecycle.
Core Requirements
REG 6190 Research Ethics
REG 5100 Introduction to Clinical and Translational Research
REG 6100 Fundamentals of FDA Regulation
REG 6120 Introduction to Drug Development
REG 6150 Post-Approval Maintenance of Drugs, Devices, and Biologics
Capstone
REG 6400 Capstone I
REG 6410 Capstone II
Electives
3 Approved Electives
Sample Study Plan
Summer
Fall
Spring
Year 1
REG 5100 Intro Clinical Research
REG 6120 Intro Drug Development
REG 6400 Capstone I
1. _________________
Year 2
REG 6100 Fundamentals of FDA Regulations
2.______________________
3.______________________
4.______________________
REG 6410 Capstone II
REG 6150 Post-Approval Maintenance of Drugs, Devices, and Biologics
For each blank, fill in:
REG 6190 – Research Ethics for either Spring Yr 1 or Spring Yr 2
3 Electives
The MRA curriculum with a concentration in quality assurance is designed to provide a broad understanding of the FDA-regulated product lifecycle with a particular focus on GLP and GMP-compliant management of product development and manufacturing.
Core Requirements
REG 6190 Research Ethics
REG 5100 Introduction to Clinical and Translational Research
REG 6100 Fundamentals of FDA Regulation
REG 6120 Introduction to Drug Development
REG 6160 Quality Assurance
Capstone
REG 6400 Capstone I
REG 6410 Capstone II
Electives
3 Approved Electives
Sample Study Plan
Summer
Fall
Spring
Year 1
REG 5100 Intro Clinical Research
REG 6120 Intro Drug Development
REG 6400 Capstone I
1. _________________
Year 2
REG 6100 Fundamentals of FDA Regulations
2. _________________
REG 6160 Quality Assurance
3. _________________
REG 6410 Capstone II
4. _________________
For each blank, fill in:
REG 6190 – Research Ethics for either Spring Yr 1 or Spring Yr 2
3 Electives
The MRA with a concentration in clinical research is designed to provide a broad understanding of the FDA-regulated product lifecycle with a particular focus on GCP-compliant management of clinical trials.
Core Requirements
REG 6190 Research Ethics
REG 5100 0Introduction to Clinical and Translational Research
REG 6100 Fundamentals of FDA Regulation
REG 6110 Clinical Study Management
REG 6120 Introduction to Drug Development
Capstone
REG 6400 Capstone I
REG 6410 Capstone II
Electives
3 Approved Electives
Sample Study Plan
Summer
Fall
Spring
Year 1
REG 5100 Intro Clinical Research
REG 6120 Intro Drug Development
REG 6400 Capstone I
1. _________________
Year 2
REG 6100 Fundamentals of FDA Regulations
REG 6110 Clinical Study Management
2. _________________
3. _________________
REG 6410 Capstone II
4. _________________
For each blank, fill in:
REG 6190 – Research Ethics for either Spring Yr 1 or Spring Yr 2
3 Electives
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, 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
8 MRA courses based on your selected concentration (see above).
LAW Courses
LAW 5110 US Law & Legal Methods (required)
LAW 5280 General Business Law (required)
LAW 5290 Navigating the Regulatory State (required)
LAW 5300 Health Law & Policy (foundational course)
LAW 5300 Health Law & Policy (foundational, replace BIOE 580)
Summer
Fall
Spring
Year 2
REG 6100 Fundamentals of FDA Regulations
LAW 5280 General Business Law (required)
REG course
LAW 5290 Navigating the Regulatory (required)
REG 6150 Post Approval Maintenance
REG 6410 Capstone II
Summer
Fall
Spring
Year 3
LAW 5110 Intro to US Law & Legal Methods (required)
LAW 5220 Compliance & Corporate Gov
LAW 5370 Fundamentals of US Legal Research
LAW 9200 Pharma Reg & Enforcement
LAW 5760 Patent Law
Experiential Learning
The Capstone is an intensive project focused on your specific area of interest within Regulatory Affairs. You will develop a detailed Capstone project with defined goals and objectives and should formulate your Capstone around a deliverable that will position you for the next step in your career. The project will be implemented under the direction of a Capstone Advisor, and you are encouraged to select your Capstone Advisor for their expertise in the topic being addressed. You are responsible for leading the design, implementation, and analysis of your work. Your Advisor will guide you, but you will drive the Capstone forward.
During the Spring of your first year in the program, you will develop your project proposal in the REG 6400 — Capstone I course. After your proposal has been approved through the successful completion of this course, you will begin your Capstone in the third term (Summer) of your first year in the program. In the Spring term of your second year in the program, you will submit a deliverable that explains the background of your study, why it is important to study, how you addressed your Capstone, and the outcomes. Your final deliverable will be evaluated by the Program Director with input from your Capstone Advisor. You will earn two credit units for completion of the Capstone — one for completion of an approved Capstone proposal (REG 640) and the second for completion of the Capstone project (REG 6410).
Sample Capstone Projects
Prepare a policy statement on an ethical consideration in human subjects research
Design a process improvement and report the outcome
Develop a regulatory guidance document
Design and implement a regulatory education training program
ITMAT Education offers a regulatory education focused internship in partnership with the Sponsor Support Unit (SSU) of the Office of Clinical Research (OCR) that lasts approximately 14 weeks.
The internship is designed to provide a mentored experience in which students gain knowledge about INDs and IDEs. Ideal students for this internship are those who have a keen eye for detail, are willing to read and review clinical trial protocols, consent forms and regulatory documents, and have an interest in sponsor roles and responsibilities.
There is a call for interns in the spring of each academic year. As we approach the call of interns, more information will be shared on how to be considered for the internship.
Additional Regulatory Education related intern or fellow opportunities will be shared as they arise.
Professional Development Workshops
The MRA program offers several professional development sessions each academic year, at least one per fall and spring semester. These sessions are open to all students enrolled in regulatory courses.
Recent topics include:
Alumni Career Panel
Survey Design Workshop
Potential/upcoming topics:
Writing in Regulatory Affairs
CV/Resume Workshop
The goal is of the professional development sessions is to assist students in their learning and growth during their time in regulatory coursework. These sessions aim to assist students in fostering skill sets that will further their understanding, ability, and careers.
Visit the ITMAT Education Courses page for an up-to-date listing of which courses are offered each semester, as well as dates, times, and instructors.
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
