The School of Public Health is introducing a new Regulatory Affairs track beginning this fall.
The track is intended to complement the existing M.P.H. degree in any of the School’s academic divisions and will prepare students for future roles in quality control and regulatory affairs. The track’s multidisciplinary approach reflects the full array of issues addressed in regulatory affairs, including legal requirements, ethics, clinical trials, epidemiology, risk analysis, and leadership and change management.
“This represents a unique opportunity for students to be exposed to current issues in the regulation of food and drugs in the United States,” said Robert Makuch, Ph.D., a professor of biostatistics and head of the track. “These topics touch our everyday lives by attempting to ensure that foods are safe and that only safe and effective drugs are brought quickly to the marketplace. Hardly a day goes by without news concerning these fundamental issues to our population’s health.”
Among the new courses to be offered is “Introduction to Regulatory Affairs,” which will be taught by Yale faculty and other experts. Speakers will include Peter Barton Hutt, past chief general counsel to the FDA and a member of the Institute of Medicine.
Four courses are required to complete the track. Interested students should apply during their first year in the M.P.H. program, Makuch said. The application consists of a resume and a statement of purpose (100-150 words) indicating how the track would help a student meet their academic and professional goals. Makuch and a committee of YSPH faculty will make the final decision on admissions.
Upon completion, students will be presented with a Regulatory Affairs Certificate.