UCSF-Stanford Center of Excellence in Regulatory Science

摘要 加州大学旧金山分校-斯坦福大学监管科学和创新卓越中心(CERSI)汇集了 来自两个杰出学术机构的世界级协作科学家团队，目标是 协力支持FDA保护公众健康的使命。2014年推出，我们的CERSI 重点关注使命驱动的监管科学产生的新知识，帮助FDA在其 决策。在我们的头两年里，我们开发了一种新的、颠覆性的研究范式 在监管科学方面；CERSI的研究应该是学术和FDA科学家之间的合作，以及 应根据其在以下方面的监管流程、指南或政策发生变化的可能性进行评估 对安全有效的医疗产品的批准和监测。这场竞争性更新的目标是 应用是通过教育和教育中的互动计划促进监管科学 研究，并支持FDA的科学家和加州大学旧金山分校的教职员工之间的协作互动 和斯坦福)。加州大学旧金山分校-斯坦福大学欧洲核子研究中心包括四个组成部分，每个组成部分都有不同的目标：c1。CERSI- CORE：CERSI-CORE的目标是支持我们的教育、研究和合作单位，通过提供 管理和监督以及各组成部分之间和欧洲核子研究组织之间的有效沟通 以及监管科学领域的关键利益相关者。C2。CERSI-教育：CERSI-教育的目标是 为学生、博士后研究员、教职员工和 该行业和FDA的科学家。C3。CERSI-协作：CERSI-协作的目标是 赞助和支持FDA访问科学家计划，并在以下方面举办研讨会和研讨会 加州大学旧金山分校、斯坦福大学以及FDA的监管科学。C4CERSI-研究：通过战略 合作研究努力，CERSI-Research的目标是在创新领域开展使命驱动的研究 管理科学，解决推进FDA保护公众使命的关键科学问题 健康。该提案还包含一项计划(C5)，用于利用FDA的投资和采购非联邦 资金来自私人捐赠者和行业，并通过我们的在线课程材料。总的来说，教育， 加州大学旧金山分校-斯坦福大学欧洲核子研究中心的研究和合作部分有助于加快培训和 研究创新的监管科学，推进FDA确保公众健康的使命。

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.