Johns Hopkins Center of Excellence in Regulatory Science and Innovation

摘要 美国食品和药物管理局的主要职责是保障公众的健康和福祉 通过应用科学合理的监管活动。在我们快速发展的科学领域， 这项任务的复杂性不断增加。为了帮助解决这个问题，FDA创建了卓越中心， 监管科学与创新（Regulatory Science and Innovation，CERSIs）CERSIs为机构提供了宝贵的机会， 直接与监管机构合作，同时为FDA提供访问和接触 先进的科学交流和培训，重点是FDA的监管科学优先领域。为一体 作为世界领先的高等教育机构，约翰霍普金斯大学很高兴能够扩展和扩大 我们与FDA的合作，因为我们开发了基本的新知识和工具，以推进监管 科学我们的提案利用了FDA和约翰霍普金斯大学之间的历史关系， 建立在我们在过去两年半中共同开发的基础设施之上 年我们的合作伙伴关系还有其他优势，包括大学的国际知名奖学金 在监管科学方面，一个巨大的培训平台，地理位置接近FDA， 有机操作方法。在这个新的奖项中，我们建议大幅扩大我们的能力， FDA的投资回报。为此，我们将把CERSI进一步整合到更多的学校中， 约翰霍普金斯的部门，包括生物医学工程系和放射学系 放射科学。我们还将介绍一些创新，如新的监管毒理学 课程和全球监管科学培训计划，以及近20个令人信服的科学 由于其高度相关性和对监管科学的预期影响，对提案进行了精心挑选。这些 科学探究的途径，以及与高等教育领先中心合作的更广泛机会 教育，作为一个证明的方式，FDA可以最大限度地提高其有效性，通过国家的- 21世纪世纪的艺术监管。

ABSTRACT The U.S. Food and Drug Administration's primary charge is to safeguard the health and well being of the public through the application of scientifically sound regulatory activities. In our rapidly evolving scientific landscape, this complexity of this task continually grows. To help address this, the FDA created the Centers of Excellence in Regulatory Science and Innovation (CERSIs). The CERSIs 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 regulatory science priority areas. As one of the world's leading institutions in higher education, Johns Hopkins University is pleased to extend and expand our collaboration with the FDA as we develop fundamental new knowledge and tools to advance regulatory science. Our proposal leverages the historic relationship between the FDA and Johns Hopkins and it also builds upon the substantial infrastructure that we have developed together during the past two and a half years. Our partnership also has other strengths including the University's internationally renowned scholarship in regulatory science, an immense training platform, close geographic proximity to the FDA and a nimble and organic operational approach. In this new award, we propose to substantially expand our capacity and the return on investment for the FDA. To do so, we will integrate our CERSI further into additional Schools and Divisions at Johns Hopkins, including the Department of Biomedical Engineering and Department of Radiology and Radiological Sciences. We will also introduce several innovations such as a new regulatory toxicology curriculum and a global regulatory science training initiative, as well as nearly twenty compelling scientific proposals carefully selected due to their high relevance and expected impact on regulatory science. These avenues of scientific inquiry, as well as the broader opportunities for partnership with leading centers of higher education, serve as a testament to the ways that the FDA can maximize its effectiveness through state-of-the- art regulation in the 21st Century.