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 项目总结/摘要 监管科学是一个跨学科的领域，可以改变生物医学研究和教育。作为 学术医疗中心采用团队科学方法，监管科学代表了一个平台， 研究人员可以合作解决科学挑战，并参与安全的发展 有效的医疗产品。监管科学和医学包括一个新兴的，专业的， 应用生物医学研究和教育的跨学科领域与科学，医学， 公共卫生和政策。科学证据的翻译和实际应用影响着 新药物治疗、生物制剂、器械和诊断的开发和生命周期。领域 在培训、学术和创新方面有很大的希望，可以为决策者提供信息，并提高 医疗产品的开发和应用。乔治城大学对监管科学有着既得利益 监管科学与医学计划（PRSM）。科技资源的开发 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 大学在合作研究和培训环境中提供专业的跨学科机会 监管科学家和其他投资于医疗产品创新的人。乔治敦大学 医学中心（GUMC）提供了一个独特的环境，以促进监管科学。他与 美国美国食品药品监督管理局（FDA）、美国国立卫生研究院（NIH）、行业贸易组织，以及 作为政策制定者，GUMC吸引了来自全国各地和世界各地的顶级学生到其研究生院学习。 教育项目。此外，GUMC为博士后研究员和长期研究员提供了丰富的培训机会， 为教职员工提供长期职业机会。我们建议策略性地发展我们既有的 将监管科学与创新卓越中心（CERSI）合作成为世界级的领导者， 监管科学，吸引学生，教师，调查人员和来自全国各地的创新者的参与 大学、其他学术机构、行业和政府。乔治城FDA的总体目标是 CERSI旨在创建和确保新的和现有的研究，教育，培训和科学交流 监管科学的机会。自2011年首次获奖以来，我们已经建立并完善了 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。此外，我们还利用CERSI作为一种手段， 大学内外的关系和伙伴关系，包括乔治敦-霍华德大学 乔治敦大学临床和转化科学中心（GHUCCTS; NIH支持的CTSA） 法律中心，乔治敦大学生物医学信息学创新中心（ICBI），MedStar Health， 美国药物研究和制造商（PhRMA）等。我们的CERSI基础奖 促成了这些富有成效的合作关系和项目。

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.