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: 8852338
• 负责人: IRA SHOULSON
• 金额: $ 23.17万
• 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/8852338
• 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.

乔治城大学 (GU) 监管科学与创新卓越合作中心 (CERSI) 抽象的 乔治城大学 (GU) 和 FDA 有着悠久的合作历史，这种合作关系得到了加强 地理接近、集体公共卫生利益、共同的教育和研究追求，以及 双方同意共同努力推进监管科学学科的发展。最近成立的 GU 监管科学与医学计划 (PRSM)、NIH 临床转化科学奖 (CTSA) 致 GU 和霍华德大学，以及 GU 医学中心 (GUMC)、GU 的一致承诺 法律中心 (GULC) 和 GU 继续教育学院 (GU SCS) 使我们成为合作伙伴 监管科学与创新卓越中心 (CERSI)。 我们寻求与 FDA 建立实质性联系，以提供和接受教育、培训、专业 发展、科学交流和应用研究，以促进合作、创新和成果 实现更有效和高效的产品开发和评估。我们提议建立 FDA-GU 合作 重视团队合作、学习者和教师以及广泛的科学交流的组织 (1) 教育、培训、专业成长和 (2) 研究与开发（利用 通过信息科学获取多样化数据；提高医疗产品质量的新方法 制造业）。创新包括（1）联合奖学金和知名 GU 学校的参与 医学、法律和教育，(2) 一个网站和人与人之间的努力，以宣传教育和 培训课程、促进科学兴趣交流并跟踪进展，以及 (3) 基础广泛的兴趣 以解决问题的模式运作的团体，以解决监管科学面临的挑战和障碍。 我们还计划与其他 CERSI 和我们的学术同事联系，以推进学科发展 通过组织科学论坛来促进监管科学，提供广泛的知识、研究和交流 教育。