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

项目摘要 美国食品和药物管理局（FDA）的药物评价和研究中心（CDER）是 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问题的程序，包括药物开发，药物审批， 生物研究监测、人类受试者保护和上市后监测。基于十多年的 Duke-Robert J. Margolis，MD，Center for 卫生政策（Duke-Margolis）建议继续与CDER合作，以解决一系列优先公众问题。 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 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 目的： 具体目标1：建立多学科协作研究和召集能力，以支持FDA 及其利益相关者探讨和解决与FDA监督有关的一系列关键公共卫生主题， 医疗产品、政策和监测方法和系统。我们的方法将包括广泛的 利益相关者的观点，促进确定切实可行的解决方案，并支持公众 FDA健康使命。 具体目标2：综合和提炼核心研究、利益相关者的投入以及研讨会或会议讨论 在目标1中，为所有利益攸关方群体制定具体、可操作的后续步骤和建议， 不仅仅是食品和药物管理局， 具体目标3：以公开方式向公众传播根据目标2提出的调查结果和建议， 透明和及时的方法，着眼于不断吸引利益相关者，以进一步完善和 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.