University of Maryland Center of Excellence in Regulatory Science and Innovation

项目总结： 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，以及食品和药物管理局(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管理计划以确保成功；实施监管 科学研究；并提供监管科学培训/教育计划。建议的研究项目 与FDA的高优先级主题保持一致，开发和评估改进质量和安全的方法，和/或 开发改进和简化临床和上市后评估的方法和工具。研究是 与FDA的科学家合作，并在密歇根大学雇佣了大量的研究能力。研究是 强化了强有力的培训/教育计划，其中包括讲座、研讨会、学者计划和 美国管制科学人才大赛。这些活动的总和描述了一个充满活力的， 尖端中心，激发创新思维，传播对监管科学和 实践，并产生新的知识，以支持FDA的基本使命-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, 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 management plan to ensure success; Conduct regulatory science research; and Provide regulatory science training/educational programs. Proposed research projects align with FDA high priority topics, develop and evaluate methods to improve quality and safety, and/or develop methods and tools to improve and streamline clinical and post-market evaluation. Research is collaborative with FDA scientists and employs a vast array of research capabilities at UM. Research is amplified by a robust training/educational program, which includes lectures, workshops, scholars program, and the America's Got Regulatory Science Talent Competition. The sum of these activities describe 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.