MRA Curriculum

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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. 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, 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. 

  1. REG 5100 Intro to Clinical and Translational Research (required)
  2. REG 6120 Intro to Drug Development (required)
  3. REG 6100 Fundamentals of FDA Regulation (required; replaces 1 ML elective)
  4. REG 6400 Capstone I (required)
  5. REG 6410 Capstone II (required)
  6. REG 6150 Post-approvals Maintenance, 6160 Quality Assurance, or 6110 Clinical Study Management depending on concentration
  7. 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). 

  1. LAW 5110 US Law & Legal Methods (required, replaces 1 MRA elective)
  2. LAW 5280 General Business Law (required; cannot count toward MRA) 
  3. LAW 5290 Navigating the Regulatory State (required; replaces 1 MRA elective) 
  4. LAW 5300 Health Law & Policy (foundational course) or LAWM 5510 Healthcare Compliance, Ethics, and Governance (Replaces REG 6190)
  5. 1 upper-level JD course 
  6. 1 upper-level JD or ML course 

Additional JD & ML LAWM courses may be viewed in the graduate course catalog


Sample Study Plan 

 

Summer

Fall

Spring

Year 1

 

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 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).

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

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.

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 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.    

Regulatory Affairs Courses

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

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
  • REG 6250 Manufacturing Novel Therapies & Imaging Agents 
  • REG 6260 Patent Law for Drug Development
  • LAWM 5360 Fundamentals of US Legal Research 

 

Classes that may not be offered online: 

  • REG 6220 New Trends in Medicine & Vaccine Discovery
  • MTR 6200 Commercializing Translational Therapeutics
  • HCMG 8990 Management & Economics of the Pharma, Biotech & Medical Device Industries
  • PUBH 5020 Introduction to Epidemiology
  • LAW 5220 Compliance and Corporate Governance 
  • LAW 5290 Navigating the Regulatory State
  • LAW 5300 Intro to Health Law & Policy 
  • LAW 9200 Pharmaceutical Regulation & Enforcement
  • BMIN 5010 Intro to Biomedical Informatics
  • BMIN 5020 Databases in Biomedical Research
  • BIOE 5520 Bioethics & the Law
  • BIOE 5750 Health Policy

Please review Penn's catalogue for course descriptions. 

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