Regulatory Science

For information on the Concentration in Regulatory Science, contact Dr. Erin Wilhelm at eew6@georgetown.edu.

Regulatory Science - Understanding the principles of pharmacology are important to develop a new medical product, but once a pharmacological agent has been developed, it is important to understand how experimental therapeutics are reviewed by the FDA and approved for use by the general public. Students who are interested in developing a broad understanding of regulatory science applications to drug or biologic discovery and development should concentrate in this area. Students will learn about clinical trial design, analytical approaches necessary to generate data for evidence-based decision-making, and the behavioral or social science skills that are needed to communicate to the public about both risks and benefits of pharmacological agents, among other topics. Knowledge gained in this concentration will be useful for students interested in careers in research, government regulatory agencies, clinical practice, pharmacy, public policy, or industry.  The Regulatory Science concentration is appropriate for students who are interested in developing (1) broad understanding of regulatory science applications to public health, (2) enhanced analytic skills and methods for evidence-based decision-making, (3) an understanding of the role of novel technologies, tools, and approaches to assessing safety and quality of medical, food, or tobacco products, and (4) behavioral and social science skills in communicating risk and benefit. The Regulatory Science concentration includes didactic instruction, student-led and mentored exercises, experiential learning opportunities, and discussion in carefully structured courses. Students may pursue the Regulatory Science concentration by taking 7 or more credits from among the following courses:
Required (2 credits)
PHAR620  Introduction to Regulatory Science (2 credits - Wednesday, 6:00 pm-8:00 pm)
Elective (5 or more credits)