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: 9524938
• 负责人: RUSS BIAGIO ALTMAN
• 金额: $ 6万
• 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/9524938
• 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.

抽象的 加州大学旧金山分校-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，其目标是 我们的 CERSI 于 2014 年启动，共同支持 FDA 保护公众健康的使命。 专注于任务驱动的监管科学——产生新知识，帮助 FDA 进行监管 在我们的头两年里，我们开发了一种新颖的、颠覆性的研究范式。 监管科学领域的 CERSI 研究应由学术界和 FDA 科学家合作，并且 应根据其改变相关监管流程、指南或政策的潜力进行评估 此次竞争更新的目标是安全有效的医疗产品的批准和监控。 应用程序是通过教育和互动项目来推进监管科学 研究，并支持 FDA 科学家和 UCSF 教师之间的合作互动 加州大学旧金山分校-斯坦福大学 CERSI 包括四个部分，每个部分都有一个独特的目标：C1。 核心：CESI-Core 的目标是通过提供以下服务来支持我们的教育、研究和合作单位： 管理和监督，以及各个组成部分之间以及 CERSI 之间的有效沟通 CERSI-教育的主要利益相关者：CERSI-教育的目标是 为学生、博士后研究员、教师和人员提供最先进的培训和教育计划 CERSI 合作的科学家：CERSI 合作的目标是 赞助和支持强大的 FDA 访问科学家计划，并在以下国家举办研讨会和研讨会： UCSF 和斯坦福大学以及 CERSI-Research 的监管科学：通过战略。 协作研究工作，CERSI-Research 的目标是在创新领域开展任务驱动的研究 监管科学解决关键科学问题，以推进 FDA 保护公众的使命 该提案还包含一项利用 FDA 投资和采购非联邦资金的计划 (C5)。 来自私人捐助者和行业以及我们的在线课程材料的资金。 加州大学旧金山分校-斯坦福大学 CERSI 的研究和合作部分旨在加速培训和 创新监管科学的研究并推进 FDA 确保公众健康的使命。