We assembled the plan, presented it, and our professor submitted all of the plans to the organization to see if they wanted to use any pieces of it. It was great to learn the processes involved, dive into public health and apply what we learned in real time.
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.
The Yale School of Public Health is partnering with Tevogen Bio, a clinical stage biotechnology company, on a major expansion of the school’s regulatory sciences program.
Regulatory Affairs Track
Notice of Intent
Regulatory Affairs Course Requirements (4 course units)
- BIS 575 Introduction to Regulatory Affairs - 1 unit
- 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
- HPM 564 Vaccination Policy and Politics - 1 unit
- HPM 559 Big Data, Privacy, and Public Health Ethics - 1 unit