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. The first speaker will be Peter Hutt, who will deliver his talk, “Regulatory History in the U.S. for the Past 220 Years” from 10:00 a.m. until noon in Winslow Auditorium at 60 College Street, New Haven. He also will give a lecture, from noon to 1:00 p.m., on FDA regulation of labeling and advertising.
Hutt is a senior counsel in the Washington D.C. law firm of Covington & Burling, specializing in food and drug law. He has represented the national trade associations for the food, prescription drug, nonprescription drug, dietary supplement and cosmetic industries. He is also a member of the Institute of Medicine, the past Chief General Counsel to the FDA and coauthor the book Food and Drug Law.
“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,” said Robert Makuch, director of the program and a professor in the Department of Biostatistics.
The Regulatory Affairs Track, established in 2010, prepares masters of public health students for roles in the areas of quality control and regulatory affairs. It is the only certificate-based training program in the country that focuses on global regulatory affairs for drugs and medical devices. Some 85 graduates of the program are now working in both the public and private sectors, including at the FDA and in Fortune 500 companies.
In addition, the Regulatory Affairs Track runs training programs for senior delegations of the Chinese Food and Drug Administration (CFDA) both in New Haven and at Shanghai Jiao Tong University.
The approach of the track is multidisciplinary to reflect the full array of issues including legal requirements, ethics, clinical trials, epidemiology, risk analysis, and leadership and change management, said Makuch.
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.
Robert Makuch, direct, Regulatory Affairs Track
Other talks in this series will be given by:
Nathan Schactman, April 7 at noon Laboratory of Epidemiology at 60 College Street, New Haven.
Schactman's practice in New York has over 30 years of experience in the defense of product liability suits, with an emphasis on the scientific and medicallegal issues that often dominate such cases. His trials, hearings, and appeals have involved prescription and overthecounter medications, medical devices, and exposure to toxic substances from products and environmental sources.
Dr. Lee Simon, April 14 at noon, Winslow Auditorium, Laboratory of Epidemiology at 60 College Street, New Haven.
Dr. Simon served as the FDA's Division Director of Analgesic, Antiinflammatory and Opthalmologic Drug Products (20012003). He served in multiple FDA advisory committees and has extensive experience in drug development as a senior investigator for Celecoxib in the US.
Joseph Scheeren, April 21 at noon, Winslow Auditorium, Laboratory of Epidemiology at 60 College Street, New Haven.
Scheeren is the Global Regulatory Affairs Head for the Pharmaceuticals and Consumer Care division at Bayer Healthcare. He has more than 20 years of global industry experience. His talk will give a snapshot of the dynamic regulatory environment in China.
Yute Wu, April 28 (by invitation only).
Wu, M.P.H. ’00, Ph.D. ‘05, is the FDA's Division Director for Generic Drugs.