Regulatory Affairs Track

Jina LiJina 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.

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.

Application

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 Version

Download the PDF versionof the Regulatory Affairs requirements.
Students enrolled in the Regulatory Affairs Track must fulfill the requirements of their respective divisions or programs. In addition, the Regulatory Affairs Track requires the student to complete four courses. All “a” courses are offered in the fall term, and “b” courses are offered in the spring term.

Requirements Completed

TRACK REQUIREMENTS

Course Units

BIS 575b
Introduction to Regulatory Affairs                                          

1

BIS 540a
Fundamentals of Clinical Trials                                              

1

Two of the following electives:

BIS 561b Advanced Topics in Multicenter Clinical Trials                                  

1

CDE 650a Introduction to Evidence-Based Medicine and Health Care

1

EHS 511a Applied Risk Assessment                                                   

1

EMD 583b Public Health Surveillance                                                

1

HPM 570a Cost-Effectiveness Analysis and Decision Making                       

1

Revised 7/12/12

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.