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. Christopher Robertson, JD, PhD, associate dean for research and innovation at the James E. Rogers College of Law, serves as faculty chair of the program.
The program offers a one-credit, interprofessional, colloquium-style course in regulatory science, open to graduate and professional students in law, medicine, nursing, public health and pharmacy. (Cross listed in the UA course catalog as EPID LAW NURS PCOL PHSC 695D)
The course is offered both fall and spring semesters and is available to students on both the UA main campus in Tucson and the UA College of Medicine Phoenix campus. The campuses connect by video conference, with an instructor at each site. Course speakers can deliver their lectures from either location, and lectures are opened and publicized to the larger law and health-sciences communities on both campuses as the Regulatory Science Series. Courses are also 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.