Master of Professional Studies in Regulatory Affairs

Course Details

The coursework required for the Master of Professional Studies in Regulatory Affairs includes two core courses, Ethics and Capstone, as well as foundation and elective coursework. Below represents a sample of course offerings. Format and content may change.

Core Courses

MPRA 500: Ethics of Regulatory and Clinical Affairs
The Ethics course is a core course in all Georgetown SCS MPS programs. In the first part of this course, students are introduced to ethical methodologies, principles, values, and frameworks. In the second part of the course, students study discipline- and field-specific codes of ethics within the profession. The course explores the ethical responsibilities of all regulatory affairs professionals to themselves, corporations, the government, and the public. Discussions include ethical situations based on past and current real-world scenarios, with topic discussions focusing on the ethical issues faced by regulatory professionals. During their final project, students codify an individual code of ethics in relation to professional codes of conduct.

MPRA 900: Capstone
The Capstone course provides an opportunity for students to apply what they have learned in the program by producing a substantive piece of work under the tutelage of an industry advisor and program faculty. Projects are aligned with students’ chosen areas of interest. Students have the opportunity to present their work to industry professionals for review and feedback. Each student receives assistance in devising a strategy to support his or her topic of interest, consistent with the course goals, by the end of the semester. Classroom assignments and lectures also focus on preparing students for successful regulatory affairs careers after they graduate from the program.

Foundation Courses

MPRA 600: The Regulation of Pharmaceuticals
This course offers a comprehensive overview of the development of pharmaceuticals and relevant regulations in preclinical programs, clinical research, regulatory submissions, and post-marketing surveillance. Students review FDA regulations for nonclinical testing, clinical testing, good laboratory practices, and the marketing of pharmaceuticals. Related laws such as the Prescription Drug User Fee Act (PDUFA) are reviewed in depth. Students learn to complete processes such as the FDA’s Investigational New Drug Application (IND) and New Drug Application (NDA). By the end of this course, students will understand how to adhere to regulatory and compliance requirements for pharmaceuticals and effectively address the concerns of regulators.

MPRA 610: The Regulation of Medical Devices
This course is designed to provide students with a comprehensive understanding of medical device development in the U.S. The course discusses the FDA’s role in approving new medical devices. It also details FDA strategies for inspecting medical device manufacturing sites and the compliance actions that may result from these inspections. Finally, the course covers new initiatives designed by the Center for Devices and Radiological Health (CDRH), the evolving regulations for clinical research of medical devices, 510(k) notification process, as well as other regulatory submissions and their review processes. Students in this course are prepared with the most important regulatory resource materials needed to understand agency policies and enforcement actions. Upon completion of the course, students will be well versed in the product development/approval process, regulatory submissions, post-market controls, and risk management.

MPRA 620: The Regulation of Biologics
In this course, students learn the scope of regulations that apply to biologics. Students study the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for each, the unique aspects in the development of specific biologics (such as vaccines and cellular therapy), and the different ways that FDA agents regulate product development. Students gain familiarity with the regulatory centers related to biologics regulations, including the FDA’s Center for Biologics Evaluation and Research (CBER). This course reviews FDA regulations, biologic regulatory submissions, such as the Biologic License Application (BLS), and related laws including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. The course also provides expert perspectives on quality assurance practices for biologics, as well as current manufacturing regulations. By the end of this course, students will be equipped with the skills needed to complete the U.S. biological product approval process, from preclinical testing, manufacturing, and marketing, to the post-marketing phase of product development.

MPRA 630: Food, Drug, and Cosmetic Act and Laws
This course explains how the FDA governs the safety and efficacy of medical products, including prescription and over-the-counter drugs, cosmetics, medical devices, blood and tissue products, and the nation's entire food supply (excluding meat and poultry). Students examine the Federal Food, Drug, and Cosmetic Act (FDCA) (52 stat. 1040) and learn about significant amendments to food and drug regulations since the FDA’s inception in 1938. By the end of the course, students will be prepared to operate effectively within the regulatory environment to ensure legal compliance.

MPRA 640: Principles of Good Manufacturing Practice
The development of new drugs and medical devices must comply with laws set by the federal government. This course equips students with the knowledge and methodologies of Current Good Manufacturing Practices (cGMP)—the most up-to-date FDA regulations related to the manufacturing of medical products and devices. The course examines the difference between U.S. manufacturing regulations and those found in Canada and Europe. Upon completion of the course, students will be prepared with the essential tools needed to implement and maintain cGMP compliant systems through scientific research, critical process analysis, and critical process control.

MPRA 650: Regulations of Human Experimentation and Good Clinical Practice
This course provides a comprehensive review of laws, regulations, and policies related to human experimentation. It covers current regulations that govern the design, conduct, performance, monitoring, recording, analysis, reporting, and auditing of clinical trials that involve human participants. The course also equips students with the skills and knowledge needed to confirm that experimental data and results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Additionally, the course explores methodological issues of human experimentation and the ethical, clinical, and financial aspects of clinical trial studies.

Sample Elective Courses

MPRA 700: Regulatory Labeling and Promotional Principles of Medical Products
As stipulated in the Federal Food, Drug, and Cosmetic Act (FDCA), medical products are required to disclose true and complete information regarding their effects and potential side effects in product labeling and other marketing communications. This course serves as an introduction to the regulations that govern product marketing and labeling. Students examine case studies and learn how to create both product labels and marketing copy that comply with regulatory laws for multiple types of medical products.

MPRA 710: Regulatory Submissions Practicum
The Regulatory Submissions Practicum is designed to provide students with the knowledge and skills needed to write medical device submissions for both U.S. and international regulatory agencies. Topics include the major regulations that govern medical device development, such as the Investigational Device Exemption (IDE), Pre-Market Approval applications (PMA), and the Pre-Market Notification 510(k), as well as the medical device development process and clinical study documents. The course prepares students to create various regulatory documents, including investigator brochures, clinical trial reports, and IDE/510 (k)/PMA submission components. The practicum also teaches students how to effectively write drug submissions for marketing applications in the U.S. and international markets. Course topics include the major regulations that govern medical drug development, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), as well as the drug development process and clinical study documents. Students have an opportunity to create applicable regulatory documents, including investigators brochures, clinical trial reports, and components of IND/NDA submissions.

MPRA 720: Strategic Planning and Project Management in Regulatory and Clinical Affairs
This course introduces strategic management as a process of formulating, defining, implementing, and evaluating regulatory policies. Students learn the core concepts of strategic planning and project management that aid medical organizations in achieving their goals and objectives. The course examines project management practices in regulatory projects that are complicated, time-constrained, and resource-intensive. Students learn not only how to guide project teams through the design and development stages, but also how to effectively monitor projects throughout their duration.

MPRA 730: Major International Markets in Regulatory Affairs
When developing new medical products, regulatory affairs professionals must ensure that the products not only conform to relevant laws in the United States, but also observe the laws in other major markets. This course seeks to equip students with a foundational understanding of regulatory laws in major international markets for new medical products—including Europe, Canada, China, and Japan. Students study the historical and current regulatory laws in these countries while examining case studies of successful and unsuccessful international product launches. By the end of the course, students will be prepared to strategically approach medical product development for international markets.

MPRA 740: Clinical Research Strategy and Managing of Clinical Trials
Well-designed clinical trials are essential in the development process of a medication or device. This course examines basic study designs, research models used to optimize study design, and the unique features of clinical trials in specialized populations. It also provides students with a foundational understanding of statistical analysis, examines effective methods for the enrollment of subjects in clinical trials, explores ethical issues in clinical research, and includes a comprehensive review of regulatory requirements. Students become familiar with various clinical research designs and statistical analyses utilized in medical product research. Additionally, students learn about opportunities for accelerating drug development and enhancing the value of scientific and business research.

MPRA 750: Introduction to Drug Safety and Pharmacovigilance
The goal of this course is to prepare students to apply the principles of drug safety pharmacovigilance—the practices used to report unexpected side effects that are discovered after a medical product is taken to market. This course provides knowledge of the principles of pharmacovigilance and proactive strategies for meeting regulatory requirements for medical devices, biologics, and drug safety risk management. Course content includes surveillance regulations, guidance on characterization and classification of adverse drug reactions, risk assessments, and required actions following product assessment. Students learn how pharmacovigilance practices are integrated into the cross-functional development plans of new drugs and biologics products in the U.S. and Europe. By the end of this course, students will be able to successfully develop a pharmacovigilance plan.

MPRA 760: Institutional Human Research Protection Program (HRPP) Management
This course addresses management of the institutional-level Human Research Protection Program (HRPP), including topics such as the conceptualization and implementation of an HRPP; Institutional Review Board (IRB) management; development and revision of institutional-level policies and administrative processes; responsible conduct of research (RCR) training for investigators, staff, and students; the Federal Wide Assurance (FWA) issued by the U.S. Department of Health and Human Services (HHS) and other federal assurances; program improvement activities and audits; institutional accreditation; eIRB systems and institutional record-keeping; role and interaction with institutional offices that are part of the HRPP, such as contracting and office of general counsel; and evaluation of program effectiveness. The course addresses practical issues involved in successful implementation of an HRPP in various institutional settings, with an emphasis on the college/university, medical centers, and other organizations in the private and public sectors that conduct and support research involving humans.

MPRA 770: United States Federal and State Human Research Oversight Systems
This course provides an in-depth review of human research policies and oversight systems currently in place in departments and agencies of the United States Federal government, including agency-specific requirements associated with the conduct and support of research involving humans. The course addresses the legal basis for these requirements, and provides a detailed review of the federal rule-making process through which regulations are created and amended over time. The course also reviews state-level requirements in the United States that are relevant to the conduct and support of human subjects research and clinical investigations.

MPRA 780: Advanced Research Ethics
This seminar addresses specialized topics in applied research ethics, including ethical issues encountered in: research with vulnerable populations; the design of clinical trials; subject selection; community-level involvement and consent; public health activities; social research, including ethical and regulatory considerations; big data and the collection and research use of large data sets; use of genomic data; risk and benefit analysis in human subjects research; privacy and confidentiality in the digital age; and international research. Students should expect to observe/participate in real-world settings where ethical issues in research are defined and debated. Particular topics may vary by semester.

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