Master of Regulatory Affairs


MRA Curriculum

The MRA curriculum is designed for working professionals, and it involves a variety of experts from UPenn, CHOP, Industry, and the FDA. We encourage students to continue their full-time position and take two courses each term towards the MRA degree. The courses are scheduled in the evenings with hybrid in-person and online components.

The MRA degree requires 10 credit units including coursework and a capstone.


Core Courses & Schedule:

  Summer Fall Spring
Year 1  

BIOE 601 Intro to Bioethics


REG 510 Intro Clinical & Translational Research

REG 612 Intro to Drug Development


Elective

Year 2

REG 610 Fundamentals of FDA Regulation


REG 611 Clinical Study Management

REG 613 Drug Development Decision Criteria


Elective

REG 640 Capstone


Elective

View Description of Required Core Courses

Required Core Courses

REG 510 Introduction to Clinical and Translational Research
Course Director: Emma Meagher, MD

This introductory course lays the foundation for understanding practical aspects of conducting clinical research in an academic environment. The course is divided into two modules: Module 1: Research Methods & Protocol Development and Module 2: Regulatory Environment for Clinical Trials. The first module introduces clinical research, clinical protocols, study designs and biostatistics that underlie such studies. The second module covers ethical considerations in clinical research, study execution and oversight, and the regulatory environment for clinical research. Upon completion, students should have a strong foundation in the fundamentals of clinical research and should be able to apply contemporary research tools to clinically relevant areas of investigation.

REG 610: Fundamentals of FDA Regulation
Course Director: Monica Ferrante, DPA

This introductory course provides an overview of Regulatory Affairs in relation to three key areas of development: Drugs, Biologics, and Medical Devices. The course will look at the rules governing prescription and over-the-counter drugs as well as the changes introduced by the influence of genetic engineering and biological product development. The developmental and regulatory path for new devices, as well as the way products are governed once in the marketplace will be explained. Throughout the course, practical issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and keep product approval will be addressed.

REG 611: Clinical Study Management
Course Director: Emma Meagher, MD

This course will focus on the practical aspects of executing clinical trials in an academic environment in a GCP compliant fashion. Upon course completion students will be able to effectively implement and manage both investigator-initiated and industry-sponsored clinical research studies. Students will be guided through the operational aspects and regulatory processes for the three stages of study management: pre study, study start-up and implementation, ongoing compliance and study close out . Students will learn strategies for navigating the complex regulatory/operational clinical research environment and for successful protocol development and approval, subject recruitment, data management and IRB/FDA interactions. Protection of human research subjects and adherence to good clinical practices guiding research in humans is a critical concept that will be integrated throughout each of the lectures.

REG 612 Introduction to Drug Development
Course Director: Jeffrey Barrett, PhD, FCP

Drug development is the process by which new chemical entities are discovered, studied in laboratory and preclinical models and investigated clinically in patients to determine if they are safe and efficacious. This introductory course lays the foundation for conducting pharmaceutical research in many ways. It begins with a brief review of the history of drug development and explains the phases of drug development in detail. The decision making process, drug development milestones and compound progression metrics are defined and explained with examples. At the conclusion of this course, students should have a working knowledge of the drug development process, understand the regulatory basis by which new chemical entities are evaluated and ultimately approved and appreciate the time and expense of drug development.

REG 613 Drug Development Decision Criteria
Course Director: Jeffrey Barrett, PhD, FCP

Drug development is a highly regulated process with a great deal of oversight provided by both the global regulatory community and the internal management of the companies themselves. This course reviews the critical junctures over which innovative and generic drugs are evaluated and the decision criteria used to judge performance and plan next steps. The nature of the collective data under review, the decision paths and the decision makers themselves often change depending on the stage of development. This course covers decision criteria from drug discovery through post marketing and even entertains decision points for generic drugs (pharmaceutical- and bio- equivalence). Metrics for evaluation, company and regulatory expectations and the tools used to facilitate decision (e.g., modeling and simulation techniques to generate “what if” scenarios) making are all discussed in detail.

BIOE 601: Introduction to Bioethics

This course is intended to serve as a broad introduction to the field of bioethics. The course will focus on several of the most important areas in bioethics, including: End-of-Life; Professional Responsibility; Reproductive Ethics; Conflict of Interest; Confidentiality; and Human Subjects Research.

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Electives:

In addition to the required courses, students must take three electives totaling three course units. Electives must be graduate level courses in an area of concentration that complements the student's future career plans in regulatory affairs.

Elective Options

Elective

This list of electives (.doc) is a representative sample of the elective course options. MTR and REG electives can be seen below.  Elective courses outside of the Perelman School of Medicine can also be considered. Your choice of elective requires prior approval from the REG administrative office.

MTR 620 Translational Therapeutics: 1 c.u. (Spring semester)

Content is focused on an overview of methodological approaches to the discovery, preclinical evaluation, and clinical development of novel therapeutics including devices, small molecules, biologics, vaccine, cell based therapies, and antibodies. Practical steps needed for real world transfer of academic technology to the patient setting will be emphasized including disclosure, patenting, licensing, business development and marketing.

REG/MTR 621 Cell & Gene Therapy: 1 c.u. (Spring semester)

This course will provide students with a general overview of translational research in the area of gene and cell therapy.  This would include technical considerations, translating preclinical investigation into therapeutics, the execution of gene and cell therapies clinical trials, and key regulatory issues. Entrepreneurial considerations will be discussed as well. By the end of this course, students will understand the basic technologies employed for gene and cell therapy along with approaches and pitfalls to translating these therapies into clinical applications including regulatory and commercial aspects of this emerging area.

REG/MTR 622 New Trends in Medicine and Vaccine Discovery: 1 c.u. (Fall semester)     

Modern drug discovery has evolved beyond small molecule drugs to include various biological approaches from proteins to cell and gene therapy, which has enabled progress in a variety of fields, including rare diseases, immuno-oncology, precision medicine, and biomarkers. The goal of this course is for students to understand newer treatment modalities and approaches beyond ‘one size fits all’ small molecule drugs, as well as the technologies that empower them. Students will learn regulatory processes that govern medicine discovery and development and also consider business and societal aspects of medical progress. Students will be able to apply concepts directly to work in the healthcare industry. Students will be taught by prominent experts in the field internal and external to Penn.

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Capstone:

REG 640: Capstone

The capstone project is an intensive learning experience focused on the student’s specific area of interest within Regulatory Affairs and his/her overall career aims. Each MRA student will be mentored by their capstone advisor. The student will develop a detailed project proposal with goals and objectives. The project will be implemented under direction of the advisor, and students will be evaluated at the end of the project.

Description of Capstone

Capstone

Completion of the capstone is required. Students will develop a detailed project proposal to define goals and objectives. The Capstone Advisor will be selected for expertise in the topic being addressed. Projects may align with the day to day responsibilities of the student's employment or it may be in a new area of interest. Throughout their second year in the program, students will implement the work under supervision of the Capstone Advisor. In the final term, students will submit a final scholarly paper.

Sample Capstone Projects

  • Prepare a risk assessment of an environmental toxicant
  • Perform post-marketing surveillance of drug adverse effects
  • Prepare a policy statement on an ethical consideration in human subject research
  • Report on a practice change implemented and the outcome
  • Design a process improvement

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Disclaimer

Please note that policies concerning admissions, curriculum, funding and financial aid are subject to change. Additionally, though variations in the curriculum may be possible, any changes will need prior approval and may have financial implications. This website is meant to provide preliminary general overview information only. Students interested in or enrolled in the program should seek personal advising from relevant faculty and staff.