Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI)

监管科学与创新卓越合作中心 (CERSI)

• 批准号: 8333867
• 负责人: IRA SHOULSON
• 金额: $ 95万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2014-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8333867
• 关键词: Collaborating; Centers; Excellence; Regulatory; Science

Georgetown University (GU) Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) Abstract Georgetown University (GU) and the FDA share a long history of collaboration that has been fortified by geographical proximity, collective public health interests, common educational and research pursuits, and mutual accords to work together in advancing the discipline of regulatory science. The recent establishment of the GU Program for Regulatory Science and Medicine (PRSM), the NIH Clinical Translational Science Award (CTSA) to GU and Howard University, and the concerted commitments of the GU Medical Center (GUMC), GU Law Center (GULC) and GU School of Continuing Studies (GU SCS) position us to serve as a Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI). We seek a substantive interface with the FDA to provide and receive education, training, professional development, scientific exchange and applied research that will promote collegiality, innovation and outcomes toward more effective and efficient product development and evaluation. We propose a cooperative FDA-GU organization that values teamwork, learners and teachers, and wide-ranging scientific exchange with parallel programs in (1) education, training, professional growth and (2) research and development (harnessing diverse data through information sciences; new approaches to improving the quality of medical product manufacturing). Innovations include (1) joint scholarship and engagement of well-known GU schools devoted to medicine, law and education, (2) a website and person-to-person efforts to inform about educational and training offerings, facilitate exchange of scientific interests, and track progress, and (3) broad-based Interest Groups operating in a problem-solving mode to address the challenges and barriers facing regulatory science. We also plan to reach out to other CERSIs and our academic colleagues to advance the discipline of regulatory science by organizing scientific forums that provide broad exchange of knowledge, research and education.

乔治敦大学（GU） 监管科学与创新卓越合作中心（CERSI） 摘要 乔治敦大学（GU）和FDA有着悠久的合作历史， 地理上的邻近，集体的公共卫生利益，共同的教育和研究追求，以及 共同努力推进监管科学学科的相互协议。最近设立 GU监管科学与医学计划（PRSM），NIH临床转化科学奖 （CTSA）对GU和霍华德大学，以及GU医疗中心（GUMC），GU 法律中心（GULC）和GU继续研究学院（GU SCS）将我们定位为合作伙伴， 监管科学与创新卓越中心（CERSI）。 我们寻求与FDA的实质性接口，以提供和接受教育，培训，专业 发展，科学交流和应用研究，将促进合议，创新和成果 更有效和高效的产品开发和评估。我们建议FDA-GU合作 一个重视团队合作，学习者和教师，以及与平行的广泛科学交流的组织 （1）教育、培训、专业成长和（2）研究与开发（利用 通过信息科学获得多样化的数据;提高医疗产品质量的新方法 制造）。创新之处包括：（1）联合奖学金和聘请知名GU学校专门 医学，法律和教育，（2）一个网站和人对人的努力，以告知教育和 提供培训，促进科学兴趣的交流，并跟踪进展，以及（3）基础广泛的兴趣 以解决问题的模式运作的团体，以应对监管科学面临的挑战和障碍。 我们还计划与其他CERSIs和我们的学术同事接触，以推进 通过组织科学论坛，广泛交流知识、研究和 教育