The science of developing new tools, standards, and approaches to assess
the safety, efficacy, quality, and performance of all FDA regulated products.
Regulatory Science is an interdisciplinary area of scientific research that aims to enhance the development of safe and effective medical products. Regulatory science relies on a community of scientists from diverse fields to collaborate in new ways, to generate new knowledge that will inform the regulatory decision-making process.
Innovative Research and World-Class Education
Ongoing and future research in regulatory science at Georgetown will enhance knowledge by providing new methods, models, or technologies to aid the scientific and regulatory community in using better approaches to evaluate the safety, quality, efficacy, and clinical effectiveness in the development of innovative medical products.
Enhanced educational programs in regulatory science will in turn improve communication by policy makers and implementers, clinicians, and the public about the safety, quality, and efficacy of medical products.
Center of Excellence in Regulatory Science and Innovation
The Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI) brings together the U.S. Food and Drug Administration (FDA) with experts in science and medicine from GUMC, professional development from GUMC and MedStar Health, law and health economics from Georgetown University Law Center, and continuing education and School of Continuing Studies.
Through specialized education, regulatory science at Georgetown will better inform scientists and regulatory reviewers who develop and assess experimental therapies, devices, and diagnostic tools.
Regulators, such as those at the FDA, have important public health responsibilities to ensure safety and quality of medical products. The FDA, an agency within the U.S. Department of Health and Human Services, is responsible for protecting the public health. The FDA regulatory review process assures the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, food supply, cosmetics, and dietary supplements. The university enjoys proximity to the FDA and other key partners.
The FDA has defined regulatory science as "the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products."
Program for Regulatory Science & Medicine (PRSM)
Georgetown University has created the first-of-its-kind (PRSM, or "prism"), headquartered in the Georgetown University Medical Center (GUMC). PRSM aims to engage a wide community of scientists, students, and educators in the emerging field of regulatory science.
PRSM has as its goal the advancement of regulatory science by creating specialized, interdisciplinary opportunities for biomedical research, bioethics, law, informatics, and many other fields critical to regulatory science.
Led by Director Ira Shoulson, M.D., PRSM aims to galvanize university efforts and resources to contribute to the knowledge base and teaching of regulatory science and medicine.
Leveraging the university’s relationship to FDA and proximity to federal and trade organizations, PRSM will continue to develop innovative research as well as graduate-level education in regulatory science. Forthcoming educational programs will include certificate programs, specialized online offerings, and a graduate programs.