UCSF-Stanford Center of Excellence in Regulatory Science and Innovation

摘要：UCSF-斯坦福大学监管科学与创新卓越中心（CERSI） 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科学家团队，目标是合作 支持FDA保护公众健康的使命。CERSI成立于2014年，专注于使命- 推动监管科学研究-产生有助于FDA监管决策的新知识- 制作。我们的研究为与评估相关的监管流程、指南和政策提供了信息， 监测安全有效的医疗产品。这次为期两年的竞争性续约的主要目标是 应用是推进监管科学主要通过合作研究项目之间 FDA的科学家和UCSF和斯坦福大学的教师。第二个目标是提供教育和培训 学生，博士后和科学家在医疗产品开发。研究战略包括四个方面 件.第一个组件集中在我们的基础设施CERSI-Core上。CERSI-Core的目标是 通过有效管理和监督CERSI的活动， 财务交易，向FDA和关键利益相关者报告信息，并安排互动 会议.研究战略的第二和第三部分侧重于研究。通过 作为学术界和FDA科学家之间的战略合作研究，我们CERSI研究的总体目标是 解决关键科学问题，推进FDA保护公众健康的使命。第二 组成部分主要包括八个一页的研究项目的建议，从加州大学旧金山分校的研究人员和 斯坦福大学，解决FDA的CERSI计划的优先领域。这些研究项目是为 在延长期开始时提供资金。第三部分包括20个半页的研究建议 在两年的延长期内可以得到资助。一页半覆盖的区域- 页面提案包括数据分析，临床试验设计和数字健康，以及广泛的研究 提案第四个组成部分包括利用林业发展局的投资和采购非 联邦基金来自私人捐助者，我们的机构，工业，并通过我们的教育产品。最后我们 包括一个简短章节，介绍我们CERSI的教育和推广活动， 奖学金计划，课程，研讨会，会议和其他活动。总体而言，拟议继续 UCSF-Stanford CERSI的更新申请将推进FDA的监管科学目标。

Abstract: The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) brings together a world-class team of 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 research—generating new knowledge that helps the FDA in its regulatory decision- making. Our research informs regulatory processes, guidances and policies relevant to the evaluation and monitoring of safe and effective medical products. The major goal of this two-year competing renewal application is to advance regulatory sciences primarily through collaborative research projects between scientists at the FDA and faculty at UCSF and Stanford. A secondary goal is to provide education and training to students, postdocs and scientists in medical product development. The research strategy includes four components. The first component is focused on our infrastructure, CERSI-Core. The goal of CERSI-Core is to support activities of the CERSI through effective management and oversight of the CERSI activities, monitoring financial transactions, reporting information to the FDA and key stakeholders, and scheduling interactive meetings. The second and third components of the research strategy is focused on research. Through strategic collaborative research among academic and FDA scientists, the overall goal of our CERSI research is to address key scientific issues for advancing FDA’s mission in protecting the public health. The second component consists largely of eight one-page proposals for research projects from investigators at UCSF and Stanford that address FDA’s priority areas for the CERSI program. These research projects are proposed for funding at the initiation of the renewal period. The third component includes 20 half-page research proposals that may be funded during the course of the two-year renewal period. Areas covered by one-page and half- page proposals include data analytics, clinical trial design, and digital health, among a broad range of research proposals. The fourth component consists of a plan for leveraging the FDA investment and procuring non- federal funds from private donors, our institutions, industry, and through our educational offerings. Finally, we include a short section on educational and outreach activities of our CERSI, which includes fellowship and scholarship programs, courses, workshops, meetings and other events. Collectively, the proposed continuing renewal application of the UCSF-Stanford CERSI will advance the FDA’s regulatory science goals.