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.
Curriculum for the MPH Regulatory Affairs Track
PDF VersionDownload the PDF versionof the Regulatory Affairs requirements.
Two of the following electives:
CDE 650a Introduction to Evidence-Based Medicine and Health Care
EHS 511b Applied Risk Assessment
HPM 570a Cost-Effectiveness Analysis and Decision Making
Competencies - Regulatory Affairs Track
Upon completion of the Track, students will be able to:
- Utilize the best scientific and ethical standards that prepare you to insure pharmaceutical products meet quality and regulatory standards.
- Develop/use scientific and regulatory knowledge for conducting/overseeing research and clinical studies that are required by regulatory agencies.
- Learn of processes that are used by regulatory agencies/pharmaceutical sponsors to insure clear and consistent decisions over the entire life cycle of a drug.
- Become aware of/assess risk management strategies that can be used to get new products to the market swiftly, while assuring the consumer and regulatory bodies that efficacy and safety have been preserved.