A partnership between University of Arizona Health Sciences and the James E. Rogers College of Law, the Regulatory Science Program exists to identify and pioneer smart forms of regulation and to train the next generation of advocates, regulators, scientists and clinicians about best practices in this area.
The Food and Drug Administration (FDA) defines “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.”
The FDA and the National Institutes of Health have identified regulatory barriers as one of five key difficulties with bringing new drugs, devices and diagnostics to market. According to the National Institutes of Health, the need is to “modernize our evaluation and approval processes to ensure that innovative products reach the patients who need them, when they need them.”
The Regulatory Science Program is co-directed by Leila Barraza, JD, MPH, assistant professor in the Mel and Enid Zuckerman College of Public Health, and Elizabeth Hall-Lipsy, JD, MPH, assistant professor in the College of Pharmacy. Tara Sklar, JD, MPH, professor of health law at the James E. Rogers College of Law, is the director of the Graduate Certificate in Regulatory Science.
This Graduate Certificate in Regulatory Science offers a 13-credit (four courses at 3 credits each, plus a 1-credit colloquium). The courses cover core competencies in regulatory science, including how the U.S. Food and Drug Administration is structured and regulates drugs, biologics, devices and diagnostics, from early discovery to bringing products to the market. Courses also feature an in-depth focus on policies, ethics, and regulations for clinical trials and marketing responsibilities.
The colloquium is a unique course in the certificate, with national and international industry leaders presenting on cutting-edge issues in regulatory science. The colloquium course is cross listed in the UA course catalog as EPID LAW NURS PCOL PHSC 695D and is offered both fall and spring semesters to students on the UA main campus in Tucson and the UA College of Medicine Phoenix campus as well as online. The colloquium course is attended by residents, fellows, postdocs and faculty from throughout the university.
Research and Service
The Regulatory Science Program serves as a resource for UA researchers by researching and writing memoranda in response to specific regulatory questions. The program also conducts larger scale research projects, including work that has been published in the New England Journal of Medicine and featured in the Washington Post. Finally, the group adds to UA capacity to address grant requirements for Ethical, Legal, and Social Implications (ELSI) of biomedical science.