Regulatory Affairs Track

Scheeren

Dr. Joseph Scheeren lectures on the regulatory environment in China. His overview included discussion of Chinese healthcare and pharma in a changing world, the healthcare legal system, an overview of the Chinese Food and Drug Agency, regulatory registration of new drugs, rapid regulatory changes, and a comparison of regulatory approval and post-approval requirements with the US, Europe, and Japan. 

Scheeren, joined Bayer HealthCare in 2004 and is now Senior Vice President, Head of Global Regulatory Affairs. He also serves as Head of Global Development Asia and is now located in Beijing, China. In addition, he is a member of the CIRS Regulatory Advisory Board, the advisory Board for SAFE-PHARMA and the advisory Board for the Regulatory Affairs track at Yale.

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. 

Kristie OtaKristie Ota, a student in the regulatory affairs program at the Yale School of Public Health, has been awarded a Global Regulatory Affairs (GRA) internship this summer at Bayer HealthCare Pharmaceutical in Whippany, N.J. The GRA internship program was established six years ago and attracts several hundred applicants each year with opportunities for placements in Bayer’s New Jersey, Berkeley, Berlin and Beijing offices. The internship is designed to help students understand regulatory affairs and the pharmaceutical industry. In return, the interns prepare valuable research findings from the projects they complete. Ota is a postdoctoral Fellow in behavioral neuroscience at Yale. She received her Ph.D. from Yale in 2010 and spent two years as a postdoctoral associate at the MIT/Broad Institute. At Bayer, she will work closely with the regulatory affairs senior staff on a topic of current regulatory importance to Bayer.

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