University of Maryland Center of Excellence in Regulatory Science and Innovation

项目摘要： 我们建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 和创新（M-CERSI），大学系统内的两个领先的姐妹校区的财团， 马里兰州和食品药品管理局。M-CERSI利用大学的工程，设备和技术优势 公园与生物医学和健康成果的优势在巴尔的摩。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。生长调节科学 培训/教育计划; 3.建立协作互动以促进监管科学 包括科学交流、讲习班和研讨会在内的交流活动; 4.创造新的机会， 科学研究; 5。创造利用FDA资金支持 CERSI活动。试点研究项目的建议，使UM的研究优势与六个FDA 监管科学倡议： 现代化毒理学以提高产品安全性 o支持改进产品制造和质量的新方法 确保FDA准备好评估创新的新兴技术 o通过信息科学收集各种数据，以改善健康成果 o加强社会和行为科学，帮助消费者和专业人士了解 关于FDA监管产品的决定 加强全球产品安全网 除了与FDA范围内的优先领域保持一致外，试点项目和其他M-CERSI活动也保持一致 以及CDER、CBER、CDRH、OMH、OHI和OWH特别指出的优先领域。的总和 这些活动描述了一个充满活力的，前沿的中心，激发创新思维，传播 了解监管科学和实践，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 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.