我现在很高兴介绍今天的小组成员;首先,CDR Tamara Rosbury,健康科学家和ETO事件响应小组的成员在CDRH战略合作伙伴关系和技术创新或OST办公室内准备和响应办公室的所有危害和响应办公室的划分; CDR Scott Steffen,高级计划管理官员和ETO事件在OST内准备和响应办公室的所有危害和应对措施的划分方面负责;产品评估和质量或OPEQ办公室内监管政策和组合产品人员的监管顾问Ryan Ortega博士;卫生技术第二卫生技术办公室的通用工程师Mitali Patil博士在OPEQ的心血管设备。
Mark Abzug,医学博士儿科教授(传染病)教授学术事务副主席,科罗拉多大学医学学院Aurora学院科罗拉多州学院,CO YODIT BELEW,医学博士,医学博士,医学博士,医学博士学位副主任(DAV)抗病毒师(DAV)的治疗局(DAV),新药及其药物治疗办公室(OND),Infectious Disease and Indiatious for Infectious Contriation and Cest)(OND)(OND)(OND),CORIAN和FAMITIAD CONDIAS)(OND)(OOID)(OOID)) (FDA) Silver Spring, MD Tien Bo, PharmD Global Medical Unit Head Transplant and New Programs Takeda Pharmaceuticals Lexington, MA David Byron Head of Research and Development AntiVirus Therapeutics 7 Ardsley Court Princeton Junction, NJ John Concato, MD, MS, MPH Associate Director, Real-World Evidence Analytics Office of Medical Policy, CDER FDA Silver Spring, MD Lindsay DeVries, Au.D.,博士科学审核者产品评估与质量办公室(OPEQ)设备和放射健康中心(CDRH)FDA Silver Spring,MD
CFPB Consumer Financial Protection Bureau CMS Center for Medicare and Medicaid Services CMMI Center for Medicare and Medicaid Innovation DHCoE Digital Health Center of Excellence DIME Digital Medicine Society DSM-5 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition EKG Electrocardiogram FDA U.S. Food and Drug Administration FSA/HSA Flexible Spending Account / Health Spending Account HRSA Health Resources and Services Administration IRS Internal Revenue Service ML Machine Learning NIDA National Institute on Drug Abuse NIH National Institute of Health NIMH National Institutes of Mental Health OHT-5 Office of Neurological and Physical Medicine Devices ONC Office of the National Coordinator for Health IT OPEQ Office of Product Evaluation and Quality RCT Randomized Controlled Trial RWD/RWE Real-World Data/Real-World Evidence SAMHSA Substance Abuse and Mental Health Services Administration SUD Substance Use Disorder TAP Total Product Life Cycle Advisory Program VC风险投资