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

约翰霍普金斯大学监管科学与创新卓越中心 (JH-CERSI)

• 批准号: 10544407
• 负责人: G. Caleb Alexander
• 金额: $ 20.76万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10544407
• 关键词: Johns; Hopkins; Center; Excellence; Regulatory

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.

抽象的 美国食品和药物管理局监管科学与创新卓越中心提供 机构拥有直接与监管机构合作的宝贵机会，同时为 FDA 提供服务 获得和接触以 FDA 为重点的先进科学交流和培训的机会 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 很高兴与 FDA 合作开发基础新知识和工具以推进 监管科学。我们的提议建立在这两个重要组织之间的历史性联盟的基础上， 包括数十年来在追求科学进步和最先进水平方面的交流和伙伴关系 规定。仅在过去的一年里，我们的CESI就从事了近十几项原创科学工作。 调查，重点关注监管的重要领域，从调味剂的作用 不可燃烟草制品（烟草制品中心）使用患者偏好方法 设计上肢假肢（设备和放射健康中心）。 JH-CERSI 的调查， 在监管科学办公室的管理下，与 FDA 科学家密切合作进行 创新，通过加强支撑其监管的科学来推进该机构的使命 活动。此外，这些学术活动的开展同时利用了各种额外的资源 政府和非营利性资金来源，为 FDA 提供了大幅加速发展的机会 并扩大对 CERSI 的投资。我们的 CERSI 还继续支持培训和 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 奖项中，我们提出了二十多项科学研究，重点关注：（1）高度优先的主题领域， 包括烟草，减少与医疗保健相关的感染，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 监管的质量和安全性 产品; (3) 创建方法和工具来提高临床和批准后的质量和效率 受管制产品的评估。约翰·霍普金斯大学和美国食品药品管理局携手合作 政府可以继续确保监管科学的蓬勃发展，并通过这样做，FDA 继续履行其首要职责——通过 应用科学合理的监管活动。