University of Maryland Center of Excellence in Regulatory Science and Innovation

马里兰大学监管科学与创新卓越中心

• 批准号: 10620962
• 负责人: WILLIAM E. BENTLEY
• 金额: $ 1万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10620962
• 关键词: University; Maryland; Center; Excellence; Regulatory

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.

项目概要： 我们提议对马里兰州大学监管科学卓越中心进行为期5年的更新， 创新（M-CERSI），大学系统内的两个领先的姐妹校区的联盟， 马里兰州和食品药品监督管理局（FDA）。M-CERSI利用生物医学和健康 巴尔的摩的成果优势与学院公园的工程和技术优势。旨在 包括：建立核心项目基础设施和管理计划，以确保成功; 科学研究;并提供监管科学培训/教育计划。拟议的研究项目 与FDA高优先级主题保持一致，开发和评估提高质量和安全性的方法，和/或 开发方法和工具，以改善和简化临床和上市后评价。研究是 与FDA的科学家合作，并在UM拥有大量的研究能力。研究是 通过强大的培训/教育计划，其中包括讲座，研讨会，学者计划， 美国监管科学人才竞赛这些活动的总和描绘了一个充满活力， 尖端中心，激发创新思维，传播对监管科学的理解， 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。