The Georgetown University Center of Excellence in Regulatory Science and Innovation (Georgetown CERSI) is a joint effort between the university and the U.S. Food and Drug Administration (FDA) to work collaboratively on projects that promote regulatory science, including innovative research, education, and scientific exchange.

The FDA has identified regulatory science as a cornerstone of its strategic initiatives. The Georgetown CERSI will enable development of new methods to guide decision making and ensure public health in the development of safe and effective medical products. The CERSI also responds to a growing need to ensure the FDA workforce has ready access to education, training, and research opportunities that Georgetown provides.


The Georgetown CERSI is not only an innovative collaboration between academia and the U.S. Food and Drug Administration, but also brings together the Georgetown University Medical Center (GUMC), the Georgetown University Law Center (GULC), and the and the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS).

Working within the newly formed Program for Regulatory Science & Medicine (PRSM) at GUMC, the Georgetown CERSI will establish opportunities at every level of the university. The GU CERSI will open to FDA scientists a broad array of research and education opportunities in the fields of medicine, nursing, and law, and engages faculty, students, and researchers at Georgetown in the rapidly developing field of regulatory science.


Ira Shoulson, MD, Principal Investigator
Lawrence Gostin, JD, co-Principal Investigator
Kenneth Dretchen, PhD, co-Principal Investigator
Erin Wilhelm, MPH, Project Director