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: 9306558
• 负责人: WILLIAM E. BENTLEY
• 金额: $ 10万
• 依托单位: UNIV OF MARYLAND, COLLEGE PARK
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9306558
• 关键词: University; Maryland; Center; Excellence; Regulatory

Project Summary: We propose the 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 FDA. M-CERSI leverages the engineering, device, and technologies strengths in College Park with the biomedical and health outcomes strengths in Baltimore. Five Specific Aims are: 1. Establish Core Program Support and Management Plan to Ensure Success; 2. Grow regulatory science training/educational programs; 3. Build Collaborative Interactions to Foster Regulatory Science Communications Including Scientific Exchanges, Workshops and Seminars; 4. Create New Opportunities for Collaborative Regulatory Science Research; and 5. Create Opportunities to Leverage FDA Funds in Support of CERSI Activities. Pilot research projects are proposed that align UM research strengths with six FDA Regulatory Science Initiatives: o Modernize toxicology to enhance product safety o Support new approaches to improve product manufacturing and quality o Ensure FDA readiness to evaluate innovative emerging technologies o Harness diverse data through information sciences to improve health outcomes o Strengthen social and behavioral science to help consumers and professionals make informed decisions about FDA regulated products o Strengthening the global product safety net In addition to their alignment with FDA-wide priority areas, the pilot projects and other M-CERSI activities align well with priority areas specifically noted by CDER, CBER, CDRH, the OMH, OHI, and OWH. 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： 我们建议马里兰州大学监管科学卓越中心的5年续期 和创新（M-Cersi），这是大学系统中两个领先姊妹校园的财团 马里兰州和FDA。 M-Cersi利用大学的工程，设备和技术优势 巴尔的摩的生物医学和健康成果的优势停车。五个具体目标是：1。建立 核心计划支持和管理计划，以确保成功； 2。成长监管科学 培训/教育计划； 3。建立协作互动以培养监管科学 包括科学交流，研讨会和研讨会在内的沟通； 4。创造新的机会 协作监管科学研究； 5。创造机会利用FDA资金来支持 CERSI活动。提议试点研究项目，将UM研究优势与六个FDA保持一致 监管科学计划： o现代化毒理学以提高产品安全性 o支持改善产品制造和质量的新方法 o确保FDA准备评估创新的新兴技术 o通过信息科学利用多样的数据，以改善健康结果 o加强社会和行为科学，以帮助消费者和专业人士知情 关于FDA监管产品的决定 o加强全球产品安全网 除了与FDA范围范围的优先领域保持一致之外，试点项目和其他M-Cersi活动保持一致 很好，CDER，CBER，CDRH，OMH，OHI和OWH专门指出的优先领域。总和 这些活动描述了一个充满活力的前沿中心，刺激创新思想，传播 了解监管科学和实践，并产生新知识以支持FDA 基本任务 - 促进和保护公共卫生。