Regulatory Affairs Track
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.
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