Regulatory Affairs Track

Every drug, medical device, diagnostic test, and food sold in the U.S. meets a rigorous set of standards that is intended to ensure products meet a set of safety and performance objectives. When products are transported across state lines, the U.S. Food and Drug Administration (FDA) has been given the authority through federal law (Code of Federal Regulations) to oversee sponsors producing these products. Both governmental agencies and industry sponsors must adhere to these codes.

Because science and technology are moving at an ever-increasing pace, the food, drug and medical and diagnostic device industries must ensure that quality and regulatory requirements are met. Scientists must possess the knowledge and expertise to understand the environment encompassing regulatory compliance. Other essential skills include project management and leadership, scientific tools that allow for proper risk assessment and risk management strategies, and the ability to identify and use clear communication practices to convey essential information to technical and non-technical audiences.

The Regulatory Affairs Track at the Yale School of Public Health (YSPH) represents a graduate-level standard in training Masters students. All lectures will adhere to widely accepted regulatory principles, from governmental and industry sponsor viewpoints. This Track prepares students for roles in the area of regulatory affairs. The Track is necessarily multi-disciplinary, to reflect the full array of issues that one may face in regulatory affairs science, including complex issues involving food and drug law, ethics, clinical trials, epidemiology, risk analysis and leadership. Most of these areas of expertise reside within YSPH and Yale more broadly.

Outside speakers are invited to share their regulatory experiences with students and faculty. These outside guest speakers are leaders in their areas of practice, including food and drug law, regulatory affairs at the global level, and current topics of special interest to the US FDA and international regulatory agencies.

The Regulatory Affairs Track may be combined with any MPH departmental program.

• Advisement regarding placements for summer internships between academic years 1 and 2, and job searches during spring of year 2 prior to graduation in addition to, existing and established student-faculty advisor relationships.
• Funding from the Track will provide students with registration/travel/other support to a regional meeting (i.e., Northeast/Middle Atlantic states) that is appropriate for regulatory affairs training.
• Opportunities to meet with speakers involved in this professional area.

• Students apply, preferably (but not necessarily) upon successful completion of first-semester coursework of their first year.
• Entry into “Introduction to Regulatory Affairs” course can take place either in Year 1 or Year 2 of the MPH.
• To apply, send a resume and a 100-150 word statement of purpose explaining how the Track may help you meet academic and professional goals to Dr. Makuch.
• The application will be reviewed and you will be notified in writing of acceptance into the Track
• The Track Director will inform the YSPH Registrar when a student is admitted to the Track.

• BIS 540 Fundamentals of Clinical Trials - 1 unit
• BIS 575 Introduction to Regulatory Affairs - 1 unit

Two of the following:

• CDE 650 Introduction to Evidence-Based Medicine and Health Care - 1 unit
• EHS 511 Principles of Risk Assessment - 1 unit
• HPM 570 Cost-Effectiveness Analysis and Decision Making - 1 unit
• HPM 588 Public Health Law - 1 unit
• HPM 595/LAW 20616 Food and Drug Administration Law - 1 unit

rev. 4.15.2021