REG

Research Spring REG 6100 Fundamentals of FDA Regulation 1 REG 6410

Subject

REG

Credits (min)

1

Credits (max)

1

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

to

Subject

REG

Credits (min)

1

Credits (max)

1

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

This course has two primary areas of focus: (i) proposal development and enhancement; and (ii) a focus on research and study design. (i) Proposal Development and Enhancement: Students apply foundational concepts by revising and refining their written proposal and presenting their research project throughout the course. Students receive an overview of approaches to developing an effective proposal; and guidance on how to write and present their hypothesis, specific aims, research strategy, significance, innovation, and approach using the general NIH application format. (ii) Research and Study Design: Students receive an overview of translational research principals and clinical study design approaches relevant to thesis projects designed to probe mechanisms of disease and translate results in basic research into investigations in humans. Topics include clinical and translational research methods, and study design and execution. Students are introduced to these topics through asynchronous and synchronous learning environments. At the end of the course, each student submits and presents their written proposal to their peers and a panel of reviewers for critique and feedback. Members of the panel include the students’ research mentor(s), program mentor, and thesis committee. The panel provides feedback on the proposal which the student will then incorporate into the written proposal. Students submit their final revised proposal to be reviewed and graded by their program mentor.

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

& Ethical

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

of FDA

Subject

REG

Credits (min)

1

Credits (max)

1

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

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. This course is divided into three segments. In the first segment, students will be guided through the operational aspects and regulatory processes of clinical trial management across the clinical trial life style from pre-study activities through study start-u and implementation, and ongoing compliance through 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. In the second segment of the course, students will learn about specific trial management challenges that may arise based on study type and will learn skills for navigating these challenges for investigator-initiated studies, federally-funded and commercially- sponsored research and research with unique trial management concerns such as conflicts of interest and the use of new technologies. Finally students will have the opportunity to apply the skills they have learned through a final course project which includes identification of a trial management challenge and a proposal for solutions to address that challenge. 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 and course assignments. 1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Prerequisite

REG 5100

Total Course Units 4 Minimum GPA requirement is a 2.70.

Subject

REG

Credits (min)

1

Credits (max)

1

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Drug development is complex, time consuming, and resource intense across multiple disciplines that require subject matter expertise. The goal is to obtain FDA-approval of a marketing application, which, once achieved, is a major accomplishment. However, marketing approval brings significant Sponsor responsibilities as the FDA continues to enforce strict regulatory requirements to ensure marketed products maintain their favorable benefit/risk profiles and therefore continue to offer safe and effective options for patients. This course is designed to provide students with an in depth understanding of the multiple regulatory requirements and marketing activities that take place following FDA approval, throughout the lifecycle of a marketed product. Topics include: • Post-marketing requirements • Pharmacovigilance/safety surveillance • Manufacturing throughout product lifecycle • Device regulations • Labeling considerations • Sales, marketing, advertising, and promotional activities • FDA inspections • General lifecycle management, label expansion, patent and exclusivity considerations

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Quality management encompassing quality assurance and the controls necessary across people, processes, and technology plays a critical role in the reliability and reproducibility of product development for the life science industry. As a key component of the Quality Management System (QMS), quality assurance (QA) includes all activities performed by an organization for the prevention of errors and defects. This course intends to focus on quality principles, elements of the quality system, standards and requirements as applicable to the FDA-regulated product development lifecycle. Further, the course aims to offer examples of risk based quality management approaches, quality control (QC) measures, and oversight as an aspect of inspection readiness. Application of an integrated quality management program and the interfaces between Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP) regulated activities during clinical development will also be addressed.

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Total Course Units 4 ENGR 1050

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

This course will focus on of the connection between biomedical research ethics and aspects of regulatory affairs. Students will apply frameworks for evaluating research ethics questions through the exploration of modern biomedical research topics. Students will cultivate competency in the application, and limitations, of US human subjects’ regulations. This course will prepare students to critically evaluate the ethics of specific research topics and apply ethics-informed decision-making in the regulatory affairs domain. Contemporary research ethics topics include (but are not limited to) research study recruitment, conflicts of interest, human research protection programs, informed consent, working with vulnerable populations, privacy/confidentiality, and emerging medical technology. The course will implement asynchronous videos and readings and interactive synchronous sessions; assignments include quizzes, discussions (in-class and online), and a generative final project. 1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

in Medicine and

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Drug development is at a turning point in human medicine. Over the past three decades, the development of biotherapeutics has revolutionized innovation in medicines. Efficiency and Quality Compliance are critical to achieving innovation and affordability. This course will provide an overview of the multi-dimensional nature of drug development, which involves regulatory, new technologies, statistical, and quality considerations. This course, which starts with a role-play exercise in developing a drug, will introduce the concepts which include pharmacology, toxicology, product development, clinical trials. All of these topics will be addressed based on regulatory requirements by the FDA. Risk assessment and mitigation will be discussed using discussion boards, case studies, and some invited guests. The content of the course includes seminars, case studies, project reports, and journal article reviews. In addition to the regulatory processes, the course also includes a discussion on soft-skill development such as decision making, scientific eminence, organizational structures, etc.

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Novel therapeutic and diagnostic agents (eg. CAR T cells, gene therapy for sickle cell disease, radionuclides etc.) have revolutionized modern clinical medicine. Historically, these agents were first developed in academia then transferred to industry for clinical scale manufacturing. Recently, however, some academic centers have developed clinical scale biomanufacturing facilities. Operation of these new facilities requires a unique blend of manufacturing, clinical, basic, regulatory and laboratory sciences. Examples of areas in which academic medical centers have developed in-house manufacturing include cell therapy, gene therapy and novel imaging agents. This course will cover manufacturing approaches, challenges, and controversies in each of these domains. At the completion of this course students will understand: -The general approach to development, manufacturing, quality control and regulatory compliance in academic manufacturing facilities -Critical steps in the manufacturing cycles of cell therapies, gene therapies and imaging agents -Current challenges in development, manufacturing, and maintaining regulatory compliance in academic manufacturing -Key considerations and relative merits of different positions in the current controversies surround these agents Each week includes a combination of synchronous and asynchronous work. Synchronous sessions will include instructor led discussions based on pre-recorded lectures or case-based discussions. Asynchronous material includes pre-recorded lectures and discussion board prompts to which students will respond throughout the week. One unique aspect to this course are the debates. For each debate week, two students will be assigned as debaters and will represent opposing points of view. All students will be provided with required pre-reading and pre-recorded lectures relevant to the debate topic. Ahead of the debate, the debaters will meet with an assigned faculty advisor to help to prepare. Students who are not assigned as debaters for that week will post questions to the discussion board ahead of the debate. The debate will occur during a synchronous session. The debaters will deliver a short introductory statement. This will be followed by QA with the audience. Finally, the debates will deliver a closing statement. These debates are a fun and interactive way for students to engage with controversial and evolving topics in the field. By the end of the course, students will appreciate the academic perspective on core elements of therapeutic and diagnostic agent manufacturing.

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

This course will examine the role and impact of patent law on the behavior of major players in the biotechnology and pharmaceutical industries as they navigate the regulatory process. This course begins with an overview of the current patent laws in the U.S. and how policies and recent changes to those laws affect the research and development of new medicines. This course will also examine the dilemmas created by patents as patent holders seek to bring their technology on to the market. The course will consist of synchronous and asynchronous materials and readings that will conclude with a paper and presentation analyzing a complex issue facing drug innovation and regulatory affairs. 1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

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. In addition to the regulatory milestones that designate a target molecule’s status, there are scientific hurdles that a drug candidate must traverse in order to gain passage to the next development phase. The pharmaceutical industry over time has systematically outlined critical junctures at which data, assumptions, models and experience are collated and reviewed by decision makers within the company, and many times in view of external experts, to decide if a compound should progress and also define the best course of action. 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. 1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

The Capstone is an intensive project focused on the student’s specific area of interest within Regulatory Affairs. The Capstone is composed of two course units, REG 6400, which consists of scheduled in-person and asynchronous classes focused on the Capstone proposal development and REG 6410 which consists of student-driven completion of the Capstone project. During REG 6400 the student, with the guidance of their Capstone Advisor, the Course Director, and program staff will define objectives and formulate their Capstone proposal and delineate deliverables and milestones. Successful completion of REG 6400 is determined by a finalized proposal approved by the Course Director. The work proposed in the Capstone Project proposal will be the focus of the student’s efforts in REG 6410 Capstone II. Prior to the start of this course students should have a topic idea(s) they are interested in pursuing for their capstone. This topic must be related to their area of interest within Regulatory Affairs. 1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

MRA students may perform an independent study for credit based on meeting specific educational requirements. All independent study courses require a designated MRA independent study advisor and prior approval from the program director, who will serve as course director for the class. The MRA Independent study course can be performed as an alternative to REG 6400 capstone proposal. The independent study plans must have a learning objective, plan of study and methods of assessment. These elements should be drafted by the student and must be approved by both the designated course director and program staff. The independent study plans are expected to align with the expectations of the capstone proposal writing credit. 0.5-1 Course Unit

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu

Candidates are expected to complete a thesis that involves designing a research project, writing a formal research proposal, performing the study described in it, preparing a comprehensive scholarly scientific paper reporting the results, and presenting and defending the thesis at a public seminar. At the time of application, each candidate specifies the project they will pursue, along with the lead mentor who will supervise the project. 1,2 Course Units 2026-27 Catalog | Generated 08/03/26

Subject

REG

Type

course

Edition

2026-2027

Source

catalog.upenn.edu