Professor Robert Makuch teaches Fundamentals of Clinical Trials.
Regulatory Affairs Track
Every food, drug, medical device, and diagnostic test sold in the United States must meet a rigorous set of standards that is intended to ensure that all products satisfy appropriate safety and performance objectives. The Regulatory Affairs Track prepares MPH students for roles in the areas of quality control and regulatory affairs. The approach of the track is multidisciplinary to reflect the full array of issues addressed in regulatory affairs: legal requirements, ethics, clinical trials, epidemiology, risk analysis, and leadership and change management.
Because science and technology are moving at an ever increasing pace, people in these industries must possess the knowledge and expertise to create and implement high-quality systems as well as 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.
Course work is supplemented by outside speakers who are experts in food and drug law, global regulatory affairs, and topics of special interest to the US Food and Drug Administration and international regulatory agencies. The Regulatory Affairs Track may be combined with any MPH departmental program, and students who complete the track will receive a certificate when they graduate.
The Yale School of Public Health’s Regulatory Affairs Track kicks off a series of five lectures featuring leading experts in food and drug policy on Thursday, March 31.