UCSF-Stanford Center of Excellence in Regulatory Science

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ABSTRACT The UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation (CERSI) brings together a world-class team of collaborative scientists from two outstanding academic institutions, with the goal of collaboratively supporting the FDA's mission to protect the public's health. Launched in 2014, our CERSI focuses on mission-driven regulatory science—generating new knowledge that helps the FDA in its regulatory decision-making. During our first two years, we have developed a novel and disruptive paradigm for research in regulatory sciences; CERSI research should be collaborative between academic and FDA scientists, and should be evaluated based on its potential to change in regulatory processes, guidances or policies relevant to the approval and monitoring of safe and effective medical products. The goals of this competing renewal application are to advance regulatory sciences through interactive programs in education and research, and to support collaborative interactions between scientists at the FDA and faculty at UCSF and Stanford). The UCSF-Stanford CERSI includes four components, each with a distinct goal: C1. CERSI- Core: The goal of CERSI-Core is to support our education, research and collaborations units by providing management and oversight, and effective communications among the components and between the CERSI and key stakeholders in regulatory sciences. C2. CERSI-Education: The goal of CERSI-Education is to provide state-of-the-art training and educational programs for students, postdoctoral fellows, faculty and scientists in the industry and at FDA. C3. CERSI-Collaborations: The goal of CERSI-Collaborations is to sponsor and support a robust FDA Visiting Scientist program, and conduct workshops and seminars in regulatory sciences at both UCSF and Stanford and at the FDA. C4. CERSI-Research: Through strategic collaborative research efforts, the goal of CERSI-Research is to conduct mission-driven research in innovative regulatory sciences that addresses key scientific issues for advancing FDA's mission in protecting the public health. This proposal also contains a plan (C5) for leveraging the FDA investment and procuring non-federal funds from private donors and industry and through our online course materials. Collectively, the education, research and collaboration components of the UCSF-Stanford CERSI serve to accelerate training and research in innovative regulatory sciences and advance the mission of the FDA in ensuring the public health.