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: 9931720
• 负责人: RUSS BIAGIO ALTMAN
• 金额: $ 5万
• 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/9931720
• 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 UCSF-史坦福大学监管科学与创新卓越中心（CERSI）汇集了一个 来自两个杰出学术机构的合作科学家团队的世界一流团队，目的是 协作支持FDA保护公众健康的使命。我们的Cersi于2014年推出 专注于任务驱动的监管科学 - 生成新知识，以帮助FDA进行监管 决策。在我们的头两年中，我们开发了一种小说和破坏性的研究范式 在监管科学中； CERSI研究应是学术和FDA科学家之间的合作，以及 应根据其改变与监管过程，指导或政策有关的潜力来评估 批准和监视安全有效的医疗产品。这种竞争更新的目标 应用是通过教育中的互动计划来推进监管科学， 研究，并支持FDA的科学家与UCSF教师之间的合作互动 和斯坦福）。 UCSF-Stanford Cersi包括四个组件，每个组件都有一个独特的目标：C1。塞 核心：CERSI核心的目标是通过提供我们的教育，研究和合作单位 管理和监督以及组件之间以及CERSI之间的有效沟通 和监管科学的主要利益相关者。 C2。教育：塞西教的目标是 为学生，博士后研究员，教师和 该行业和FDA的科学家。 C3。 CERSI-Collaborations：CERSI-Collaborations的目标是 赞助和支持强大的FDA访问科学家计划，并在 UCSF和Stanford以及FDA的监管科学。 C4。 CERSI研究：通过策略 协作研究工作，CERSI搜索的目标是进行创新的任务驱动研究 监管科学解决了促进FDA使命保护公众的关键科学问题 健康。该提案还包含一个计划（C5），用于利用FDA投资和采购非联邦 来自私人捐助者和行业的资金以及我们的在线课程材料。总体教育， UCSF-Stanford Cersi的研究与协作组件有助于加速培训和 创新监管科学的研究并提高了FDA的使命，以确保公共卫生。