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

乔治敦大学(GU) 监管科学与创新卓越合作中心(CERSI) 摘要 乔治城大学(GU)和FDA有着悠久的合作历史，这种合作得到了 地理上的接近、共同的公共卫生利益、共同的教育和研究追求，以及 双方同意在推进监管科学学科方面共同努力。最近成立的 美国国立卫生研究院临床转化科学奖--GU调控科学与医学计划 (CTSA)给GU和Howard University，以及GU医学中心(GUMC)、GU 法律中心(GULC)和州立大学继续教育学院(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建立实质性的联系，以提供和接受教育、培训、专业知识 将促进合议性、创新性和成果的发展、科学交流和应用研究 向更有效、更高效的产品开发和评估迈进。我们提出了一种合作的FDA-GU 重视团队合作、学习者和教师，以及并行的广泛科学交流的组织 (1)教育、培训、专业成长和(2)研究和开发(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 制造业)。创新之处包括：(1)联合奖学金和聘请知名的顾氏学校。 医疗、法律和教育，(2)一个网站和个人之间的努力，以告知教育和 提供培训，促进科学兴趣的交流，跟踪进展，以及(3)广泛的兴趣 以问题解决模式运作的组织，以应对监管科学面临的挑战和障碍。 我们还计划联系其他CERSI和我们的学术同行，以促进 通过组织科学论坛，提供广泛的知识、研究和 教育。

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.