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 Plan
All students are required to complete the 4 core courses and Capstone I in year 1.
Students then complete their electives and capstone project in year 2.
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
Elective or Concentration Course 1
Year 2
Elective or Concentration Course 2
Elective or Concentration Course 3
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)
REG 5100 Intro to Clinical & Translational (required)
REG 6120 Into to Drug Development (required)
REG 6400 Capstone I (required)
REG 6260 Patent Law for Drug Development OR REG 6150 Post-Approvals Maintenance (replaces 1 ML elective)
Summer
Fall
Spring
Year 2
REG 6100 Fundamentals of FDA Regulations (required)
LAW 5110 Intro to US Law & Legal Methods (required)
REG elective
LAW 5290 Navigating the Regulatory State (required)
LAW 5300 Health Law & Policy or LAWM 5510 Healthcare Compliance, Ethics, and Governance (foundational, replaces REG 6190)
REG 6410 Capstone II (required)
Summer
Fall
Spring
Year 3
LAW 5280 General Business Law (required)
ML or JD elective
Upper-level JD elective
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 project in the third term (Summer) of your first year in the program. The final product of the project will be a deliverable that explains the background of your project, why it is important to study, how you addressed your Capstone, and the outcomes. Your final deliverable will be evaluated by the Capstone Course Director(s) 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 6400) and the second for completion of the Capstone project (REG 6410).
Recent Capstone Titles
Training Programs
Creation, Implementation, and Evaluation via Compliance Parameters of a Continuing Drug Manufacturing Compliance Education Program within the Penn Cyclotron Facility
Tackling Learning Gaps and Operational Deficiencies in the Field of Regulatory and Compliance Using Tailored Educational Workshops
A Training System and Reference for High Throughput Xenograft Modeling in Immune Deficient Mice
Targeted Regulatory Guidance
Regulatory Pathway Guide for New Medical Devices and Technology at the University of Pennsylvania
Developing an Internal Regulatory Guidance Document for Filing a Companion Diagnostics Application
Guidance Toward Implementing a GLP Compliance Program in an Academic Setting: Overcoming Challenges and Pitfalls
Evaluation of Gaps & Challenges in Developing Rare Disease Registry Endpoints: A Case Study of PRO Endpoints in Registries for CDKL5 Deficiency Disorder and Spinal Muscular Atrophy
Implications Affecting Regulatory Preparation and Workflow for Continuing Reviews: Site-level Differences when Using Local or National IRB (CIRB) in Oncology
Review of the Proposed Model of Regulation for Plant Biostimulants and Guidance on Their Use
Process Improvement
Developing a New Master Manufacturing Batch Record
Risk-based Monitoring of Gene Therapy Clinical Trials for Hereditary Retinal Degeneration
Implementation of the CNT Imaging Core Data Collection and Analysis Pipeline
Preclinical Data Collection for Successful IDE Submission
Quality Management Systems at an Academic Research Institution: Development and Implementation of a Pilot Quality Management System at the University of Pennsylvania
Evaluating Timelines, Processes, and the Downstream Operational Activation Impacted by Differences in IRB Review Models
Review of Direct-to-Consumer Advertisement Regulations in Direct Across Worldwide Regulatory Bodies
Articles
Trends in Reporting to the FDA Adverse Events Reporting System (FAERS)
Evaluating the Impact of the New Informed Consent Ruling from the Pennsylvania Supreme Court
CAR-T Therapy Product Development and Approval in the US for the Treatment of Orphan Diseases
Deception in Human Subjects Research and the Effect of Subject Payment: Subjects’ Views and Staff Views
Longitudinal Study to Assess Long Term Comorbidities in Women with PCOS-Longitudinal PCOS
Evaluating the Impact of Chinese Regulatory Reforms from 2015-2020
Review and Recommendations Related Virtual Reality (VR) Design as it Relates to Chronic Pain
Exploration of How Social Media Data is Used in Post-marketing Pregnancy Drug Safety Research
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
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.
Ajay Parashar Memorial Symposium
In 2023, Regulatory Education launched an annual symposium dedicated to Ajay Parashar, PharmB, MS, MDD, RAC. Ajay was a beloved instructor and mentor in the MRA program always championing innovation.
The annual symposium features multiple short presentations from Regulatory Affairs affiliates and alumni sharing cutting-edge industry trends, expertise, and conversations for the benefit of current REG students and friends of the program. The symposium includes Q&A and discussion elements.
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
