Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI)

摘要 美国食品和药物管理局监管科学和创新卓越中心提供 机构有宝贵的机会直接与监管机构合作，同时向FDA提供 接触和接触高级科学交流和培训的机会侧重于FDA的 优先领域。作为世界领先的高等教育机构之一，约翰霍普金斯大学是 很高兴与FDA合作开发基本的新知识和工具，以推动 监管科学。我们的建议建立在这两个重要组织之间的历史性联盟之上， 包括几十年来在追求科学进步和最先进技术方面的交流和伙伴关系 监管。仅在过去的一年里，我们的CERSI就从事了近12项原创科学研究 调查，重点放在重要的监管领域，从调味剂在 不可燃烟草制品(烟草制品中心)使用患者偏好的方法 设计上肢假体(器械和放射健康中心)。JH-CERSI的调查， 与FDA的科学家密切合作，由监管科学办公室和 创新，通过加强支撑其监管的科学，推动了该机构的使命 活动。此外，这些学术活动是在利用各种额外的 政府和非营利性资金来源，为FDA提供了大幅加快 并扩大在欧洲核子研究中心的投资。我们的CERSI也继续支持培训和 通过课程、研讨会、 研讨会、竞赛和证书、硕士和博士学位课程。在目前提议的 作为获奖者，我们提供了二十多项科学调查，集中在：(1)高度优先的主题领域， 包括烟草，减少与保健有关的感染，并解决阿片类药物的使用、滥用和 依赖；(2)开发和评估新方法，以提高FDA规定的质量和安全性 产品；以及(3)创造方法和工具，以提高临床和审批后的质量和效率 对受管制产品的评估。约翰·霍普金斯大学和美国食品和药物管理局 政府可以继续确保监管科学的蓬勃发展，在这样做的过程中，FDA 继续履行其首要职责-通过 应用科学合理的监管活动。

ABSTRACT The U.S. Food and Drug Administration's Centers of Excellence in Regulatory Science and Innovation provide institutions with a valued opportunity to work directly with regulators while simultaneously providing the FDA opportunities for access and exposure to advanced scientific exchange and training focused on the FDA's priority areas. As one of the world's leading institutions in higher education, Johns Hopkins University is pleased to collaborate with the FDA in the development of fundamental new knowledge and tools to advance regulatory science. Our proposal builds upon a historic alliance between these two vital organizations, including decades of exchange and partnership in the pursuit of scientific advancement and state-of-the-art regulation. During the past year alone, our CERSI has engaged in nearly a dozen original scientific investigations, focusing upon vital areas of regulation ranging from the role of flavorants in noncombustible tobacco products (Center for Tobacco Products) to the use of patient preference methods to design upper limb prostheses (Center for Devices and Radiologic Health). The JH-CERSI's investigations, conducted in close partnership with FDA scientists with stewardship from the Office of Regulatory Science and Innovation, have advanced the Agency's mission by strengthening the science underpinning its regulatory activities. Furthermore, these scholarly activities have been conducted while leveraging a variety of additional governmental and non-profit funding sources, providing the FDA with opportunities to considerably accelerate and amplify the investments made in the CERSI. Our CERSI also continues to support the training and professional development of the next generation of leaders in regulation through courses, workshops, seminars, competitions and certificate, master and doctoral degree programs. In the currently proposed award, we present more than two dozen scientific investigations focused on: (1) high priority topic areas, including tobacco, reducing health care associated infections, and addressing opioid use, misuse and dependence; (2) developing and evaluating new methods to improve the quality and safety of FDA-regulated products; and (3) creating methods and tools to improve quality and efficiency of clinical and post-approval evaluation of regulated products. Together, Johns Hopkins University and the U.S. Food and Drug Administration can continue to ensure that regulatory science flourishes, and in so doing, that the FDA continues to fulfill its primary charge - to safeguard the health and well-being of the public through the application of scientifically sound regulatory activities.