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.

Past Guest Lecturers

Marguerite Callaway, YSPH

Jerry Farrell, Jr., Commissioner, CT Dept. of Consumer Protection

Ellen Flannery, Esquire, Partner, Covington & Burling, Washington D.C.

Dr. John Gadea, Jr., CT Dept. of Consumer Protection, Drug Control Division

Frank Greene, CT Dept. of Consumer Protection, Food and Standards Division

Peter Barton Hutt, Esquire, Senior Counsel, Covington & Burling, Washington DC

Richard Maloney, CT Dept. of Consumer Protection, Director of Trade Practices

Dr. Claude Petit, Executive Director, Biostatistics and Programming, Boehringer Ingelheim

Dr. Joseph Scheeren, Senior VP, Head of Global Regulatory Affairs, Bayer Pharmaceuticals

Dr. Thomas Schneppe, Head of Integrated Quality Management Bayer HealthCare AG

Dr. Jeffrey Sherman, Immediate Past President, DIA and Chief Med. Officer, Horizon Pharma

John Suchy, CT Dept. of Consumer Protection, Liquor control Division