University of Maryland Center of Excellence in Regulatory Science and Innovation

项目摘要 我们建议马里兰大学监管科学和管理卓越中心续签5年 创新(M-CERSI)，由加州大学系统内两个主要姐妹校区组成的联合体 马里兰州(USM)和食品和药物管理局(FDA)。M-CERSI利用生物医学和健康 结果：巴尔的摩的优势和学院公园的工程和技术优势。目标 包括：建立核心计划基础设施和工作计划以确保成功；开展前沿 监管科学研究；提供扩大M-CERSI活动的机制；提供监管科学 信息共享机会；并增加教师、FDA科学家获得M-CERSI机会， 以及在监管科学领域代表性不足的受训人员。拟议的研究项目与FDA的一致 监管科学框架，使FDA监管产品的开发和评估现代化， 加强FDA监管产品的上市后监测和标识，为公众健康注入活力 FDA、患者和消费者的准备和反应。所有M-CERSI研究都是与 FDA是科学家，并在马里兰大学雇佣了大量的研究能力。研究是 通过研究科学家协作计划和强大的信息共享计划来强调 机会，包括研讨会、学者计划、讲座和美国GET监管 理科人才大赛。这些活动的总和描述了一个充满活力的、前沿的中心 激发创新思维，传播对监管科学和实践的理解，并产生 支持FDA基本使命的新知识--促进和保护公众健康。

Project Summary We propose a 5-year renewal of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), a consortia of the two leading sister campuses within the University System of Maryland (USM), and the Food and Drug Administration (FDA). M-CERSI leverages the biomedical and health outcomes strengths in Baltimore with the engineering and technologies strengths in College Park. Aims include: Establish core program infrastructure and work plan to ensure success; Conduct cutting-edge regulatory science research; Provide mechanisms to expand M-CERSI activities; Provide regulatory science information sharing opportunities; and Increase access to M-CERSI opportunities to faculty, FDA scientists, and trainees who are underrepresented in regulatory science. Proposed research projects align with FDA's regulatory science framework to modernize development and evaluation of FDA-regulated products, strengthen post-market surveillance and labeling of FDA-regulated products, and invigorate public health preparedness and response of the FDA, patients and consumers. All M-CERSI research is collaborative with FDA scientists and employs a vast array of research capabilities at the University of Maryland. Research is accentuated by a Research Scientist Collaboration Program and a robust program of information sharing opportunities, which includes workshops, scholars program, lectures, and the America's Got Regulatory Science Talent Competition. The sum of these activities describes a vibrant, cutting edge Center that stimulates innovative thought, disseminates understanding of regulatory sciences and practices, and generates new knowledge in support of the FDA's fundamental mission – to promote and protect the public health.