Regulatory Affairs Track

The Regulatory Affairs Track is directed by Dr. Robert Makuch, Professor of Biostatistics, who has considerable expertise in regulatory affairs. Dr. Makuch is available to assist Track students with relevant summer internship placements. Some funding will also be available to enable students to attend a regional meeting relevant to regulatory affairs training.


Students interested in the Regulatory Affairs Track should apply during their first year in the MPH program. The application consists of a resume and a statement of purpose (100-150 words) indicating how the Track may help them meet their academic and professional goals. Admissions decisions are made by Dr. Makuch and a small committee of YSPH faculty.

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Jina Li

Jina Li, an MPH student in the Biostatistics Department and the Regulatory Affairs Track, will travel to Geneva this summer to intern with the World Health Organization under the direction of Jeremy Lauer and Melanie Bertram. Jina will conduct data management, cost-effectiveness modeling, and use statistical modeling and inference methods to give economic evaluation and advice for regulation and policy using the WHO-CHOICE costing database. The internship also includes visits to UnitAid, an international drug purchasing facility that helps developing countries with regulatory and financial processes for the complex market systems involved in obtaining drugs for HIV/AID, tuberculosis and malaria. This will broaden Jina’s perspective on drug manufacturing and pricing in different countries. Jina has been awarded funding from the Regulatory Affairs Track for this internship.