UCSF-Stanford Center of Excellence in Regulatory Science

加州大学旧金山分校-斯坦福大学监管科学卓越中心

• 批准号: 10089673
• 负责人: RUSS BIAGIO ALTMAN
• 金额: $ 4.76万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10089673
• 关键词: UCSF; Stanford; Center; Excellence; Regulatory

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.

摘要 UCSF-斯坦福大学监管科学与创新卓越中心（CERSI）汇集了 来自两个杰出学术机构的世界级合作科学家团队，目标是 共同支持FDA保护公众健康的使命。我们的CERSI于2014年推出， 专注于使命驱动的监管科学-产生新的知识，帮助FDA在其监管 决策的在我们的头两年里，我们已经开发了一种新颖的和破坏性的研究范式 在监管科学中; CERSI研究应该是学术界和FDA科学家之间的合作， 应根据其在相关监管流程、指南或政策中发生变化的可能性进行评估， 批准和监测安全有效的医疗产品。这场竞争性复兴的目标 应用是通过教育中的互动程序来推进监管科学， 研究，并支持FDA科学家和UCSF教师之间的合作互动 和斯坦福大学）。UCSF-Stanford CERSI包括四个组成部分，每个组成部分都有一个独特的目标：C1。CERSI- 核心：CERSI-Core的目标是通过提供支持我们的教育，研究和合作单位 管理和监督，以及各组成部分之间和CERSI之间的有效沟通 和监管科学的关键利益相关者。C2. CERSI教育：CERSI教育的目标是 为学生，博士后研究员，教师和学生提供最先进的培训和教育计划。 行业内和FDA的科学家C3. CERSI合作：CERSI合作的目标是 赞助和支持一个强大的FDA访问科学家计划，并举办讲习班和研讨会， 加州大学旧金山分校和斯坦福大学以及FDA的监管科学。C4. CERSI研究：通过战略 合作研究的努力，CERSI-Research的目标是进行创新的使命驱动的研究 解决关键科学问题的监管科学，以推进FDA保护公众的使命 健康该提案还包含一项利用FDA投资和采购非联邦政府项目的计划（C5）。 来自私人捐助者和行业的资金，并通过我们的在线课程材料。总的来说，教育， UCSF-斯坦福大学CERSI的研究和合作部分有助于加速培训， 研究创新的监管科学，推进FDA在确保公众健康方面的使命。