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

项目总结 美国食品和药物管理局(FDA)的药物评估和研究中心(CDER) 寻求合作研究和召开活动的建议可促进监管科学、政策和 处理一系列关键公共卫生主题的程序，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。在十多年的基础上 在这些主题上与FDA合作的经验，杜克-罗伯特·J·马戈利斯医学中心 卫生政策(杜克-马戈利斯)建议继续与CDER合作，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-马戈利斯公司提议扩大我们现有的 通过与CDER和Duke生态系统内的专家合作，与FDA合作，以促进以下工作 目标： 具体目标1：实施多学科协作研究和召集能力，以支持食品和药物管理局 及其利益攸关方探讨和解决与FDA对 医疗产品、政策、监测方法和系统。我们的方法将结合广泛的 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 追求目标1，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FDA，需要追查。 具体目标3：将根据目标2制定的调查结果和建议以 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.