Mary Beth Ritchey, PhD, FISPE has spent more than 15 years in government, industry, consulting, and academia in better understanding medical product safety and effectiveness when used in actual clinical practice. She is the Chief Epidemiologist at the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) where she provides technical insight on real-world evidence policy and leads a portfolio of projects on active surveillance and real-world evidence studies. Additionally, Dr. Ritchey is an Associate Research Professor in the Center for Pharmacoepidemiology and Treatment Sciences at Rutgers University, where she teaches, mentors fellows, and engages in medical product epidemiology research. She is adept with scientific, technical, and logistical aspects of retrospective and prospective studies, both using databases and new data collection, as well as registry governance and implementation, analyses of the regulatory landscape for novel therapeutics, and development of tools for increased collaborative research.
Dr. Ritchey’s career has encompassed roles within government and industry, and she understands the perspectives of each. During her previous tenure at the US FDA, she managed the device Postmarket Surveillance Studies (522) and literature review programs and was involved with the Medical Device Epidemiology Network (MDEpiNet) and Sentinel initiatives. Within industry, she developed data strategy tools, a continuous learning organization approach to comparative effectiveness studies, and enhanced a cross-product signal management and risk management program to include synthesis of actionable knowledge across multiple disparate data sources. As a consultant, she has partnered with clients to prepare and present regulatory positions related to real-world evidence as well as to conduct regulatory-grade feasibility, utilization, safety, and effectiveness real-world studies for postmarketing requirements, externally-controlled studies, and labeling expansions. In April 2021, Dr. Ritchey released the book Pragmatic Randomized Clinical Trials: Using Primary Data Collection and Electronic Health Records, co-edited with Cynthia Girman, DrPh.
Dr. Ritchey obtained bachelor’s degrees in chemistry (Duke University) and nursing (University of North Carolina [UNC] Chapel Hill) as well as masters and doctoral degrees in epidemiology from UNC Gillings School of Global Public Health. She is a Fellow and previous Board member (2019-2022) of the International Society of Pharmacoepidemiology (ISPE) and an Associate Editor for Pharmacoepidemiology and Drug Safety.