Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities

项目概要 美国食品和药物管理局 (FDA) 的药物评价和研究中心 (CDER) 寻求合作研究和召集活动的建议，推进监管科学、政策和 解决一系列关键公共卫生主题的程序，包括药物开发、药物批准、 生物研究监测、人体受试者保护和上市后监测。建立在十多年的基础上 与 FDA 在此类主题上合作的经验，杜克-罗伯特 J. 马戈利斯医学博士，中心 卫生政策 (Duke-Margolis) 建议继续与 CDER 合作，解决一系列优先公共问题 健康问题。通过这项新的合作协议，杜克-马戈利斯提议扩大我们现有的合作范围 通过与 CDER 和杜克生态系统内的专家合作，与 FDA 合作，以推进以下工作 目标： 具体目标 1：实施多学科协作研究和召集能力以支持 FDA 及其利益相关者探索和解决与 FDA 监督相关的一系列关键公共卫生主题 医疗产品、政策以及监测方法和系统。我们的方法将包含广泛的 利益相关者的观点，促进确定实际可行的解决方案，并支持公众 FDA 的健康使命。 具体目标 2：综合和提炼核心研究、利益相关者的意见以及研讨会或会议讨论 目标 1 旨在为所有利益相关者群体制定具体、可操作的后续步骤和建议， 不仅仅是 FDA 所追求的。 具体目标 3：以广泛的方式向公众传播目标 2 下制定的调查结果和建议 透明和及时的方法，着眼于不断吸引利益相关者进一步完善和 在可行和适当的情况下实施关键概念和建议。

PROJECT SUMMARY The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration’s (FDA) is seeking proposals for collaborative research and convening activities advance regulatory science, policy, and procedures to address a range of critical public health topics, including drug development, drug approval, bioresearch monitoring, human subject protection, and post market surveillance. Building on over ten years of collaborative experience working with the FDA on such topics, the Duke-Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) proposes to continue collaborating with CDER to tackle a range of priority public health issues. Through this new cooperative agreement Duke-Margolis proposes to expand on our existing collaboration with FDA by partnering with CDER and experts within the Duke ecosystem to advance the following aims: Specific Aim 1: Implement a multidisciplinary and collaborative research and convening capacity to support FDA and its stakeholders to explore and address a range of critical public health topics related to FDA’s oversight of medical products, policy, and surveillance methods and systems. Our approach will incorporate a wide array of stakeholder perspectives, facilitate the identification of practical and actionable solutions, and support the public health mission of FDA. Specific Aim 2: Synthesize and distill the core research, stakeholder input, and workshop or meeting discussions pursued in Aim 1 to establish concrete, actionable next steps and recommendations for all stakeholder groups, not just FDA, to pursue. Specific Aim 3: Disseminate the findings and recommendations developed under Aim 2 to the public in a transparent and timely method, with an eye toward continually engaging stakeholders to further refine and implement key concepts and recommendations where feasible and appropriate.