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: 10324074
• 负责人: WILLIAM E. BENTLEY
• 金额: $ 20万
• 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/10324074
• 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.

项目摘要： 我们建议在马里兰大学监管科学卓越中心续签5年 创新（M-Cersi），大学系统中两个领先姊妹校园的财团 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 在大学公园的工程和技术优势，巴尔的摩的成果优势。目标 包括：建立核心计划基础架构和管理计划以确保成功；进行监管 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​​和评估改善质量和安全性的方法，/或 开发改进和简化临床和市场后评估的方法和工具。研究是 与FDA科学家和员工合作，在UM与大量的研究能力合作。研究是 通过强大的培训/教育计划进行放大，其中包括讲座，讲习班，学者计划和 美国参加了监管科学人才竞赛。这些活动的总和描述了一个充满活力的， 刺激创新思想，传播对监管科学的理解和的前沿中心 实践并产生新知识来支持FDA的基本使命 - 以促进和 保护公共卫生。