Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI)

乔治敦大学监管科学与创新卓越中心 项目摘要/摘要 调控科学是一个可以改变生物医学研究和教育的跨学科领域。AS 学术医疗中心采用团队科学方法，监管科学代表一个平台，由 研究人员可以合作应对科学挑战并参与SAFE的发展 和有效的医疗产品。监管科学和医学构成了一个新兴的、专门的和 应用生物医学研究和教育的跨学科领域，应用于科学、医学、 公共卫生和政策。科学证据的翻译和实际应用影响着 新的药理疗法、生物制品、设备和诊断的开发和生命周期。田野 在培训、奖学金和创新方面大有可为，为决策者提供信息并增强 医疗产品的开发和利用。乔治城大学在监管科学方面有既得利益 通过其监管科学与医学计划(PRSM)。科技资源优势 发现和临床研究，地理上靠近监管机构和政策制定者，乔治敦大学 大学在协作研究和培训环境中提供专业的跨学科机会 针对监管科学家和其他投资于医疗产品创新的人。乔治敦大学 医疗中心(GUMC)为促进监管科学提供了独特的环境。与美国政府建立了联系 美国食品和药物管理局(FDA)、美国国立卫生研究院(NIH)、行业贸易组织和 政策制定者，GUMC吸引来自全国和世界各地的顶尖学生来其研究生学习 教育项目。此外，GUMC还为博士后和长期博士后提供了丰富的培训机会。 为教职员工提供长期的职业机会。我们建议从战略上发展我们现有的 监管科学与创新卓越合作中心(CERSI)成为世界一流的 监管科学，让来自世界各地的学生、教师、研究人员和创新者参与进来 大学、其他学术机构、行业和政府。FDA-乔治敦大学的总体目标是 CERSI是创建和确保新的和现有的研究、教育、培训和科学交流 监管科学领域的机遇。自2011年首次获奖以来，我们已经建立和完善了核心 我们计划的特点，包括乔治敦大学和FDA人员之间的合作研究项目，以及 提供教育和培训服务。此外，我们还利用CERSI作为一种手段来促进和创造 大学内外的关系和伙伴关系，包括乔治敦-霍华德大学 乔治敦大学临床与翻译科学中心(GHUCCTS；美国国立卫生研究院支持的CTSA) 乔治城大学生物医学信息学创新中心(ICBI)法律中心，MedStar Health 美国药物研究和制造商协会(PhRMA)等。我们的CERSI基础性奖项 促成了这些富有成效的合作伙伴关系和计划。

Georgetown University Center of Excellence in Regulatory Science and Innovation Project Summary/Abstract Regulatory Science is an interdisciplinary field that can transform biomedical research and education. As academic medical centers embrace team-science approaches, regulatory science represents a platform by which researchers can collaborate to address scientific challenges and participate in the development of safe and effective medical products. Regulatory science and medicine comprise an emerging, specialized, and interdisciplinary field of applied biomedical research and education with applications to science, medicine, public health, and policy. The translation and practical application of scientific evidence influences the development and lifecycle of new pharmacological therapies, biologics, devices, and diagnostics. The field holds great promise for training, scholarship, and innovation to inform decision makers and enhance the development and utility of medical products. Georgetown University has a vested interest in regulatory science through its Program for Regulatory Science & Medicine (PRSM). Advantaged by resources in scientific discovery and clinical research, and with geographical proximity to regulators and policy makers, Georgetown University offers specialized, interdisciplinary opportunities in a collaborative research and training environment for regulatory scientists and others invested in the innovation of medical products. Georgetown University Medical Center (GUMC) provides a unique milieu to promote regulatory science. With established ties to the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), industry trade organizations, and policy makers, GUMC attracts top-tier students from around the country and worldwide to study in its graduate education programs. In addition, GUMC provides a rich training opportunity for post-doctoral fellows and long- term career opportunities for faculty and staff. We propose to strategically develop our established Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) into a world-class leader in regulatory science, engaging participation from students, faculty, investigators, and innovators from across the university, other academic institutions, industry, and government. The overall aim of the FDA-Georgetown CERSI is to create and secure new and existing research, education, training, and scientific exchange opportunities in regulatory science. Since our initial award in 2011, we have established and refined the core features of our program, including collaborative research projects among Georgetown and FDA personnel, and educational and training offerings. In addition, we have used the CERSI as a means to foster and create relationships and partnerships within and beyond the university, including the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS; an NIH-supported CTSA), Georgetown University Law Center, Georgetown University Innovation Center for Biomedical Informatics (ICBI), MedStar Health, Pharmaceutical Research and Manufacturers of America (PhRMA), and others. Our foundational CERSI award enabled these productive partnerships and programs.