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Virtual

Jun 21, 2021 9:30 AM - Jun 21, 2021 12:30 PM

#012A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use

Instructors

Nancy  Dreyer, PhD, MPH, FISPE

Nancy Dreyer, PhD, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise includes patient-generated information, electronic health records, health insurance claims, and data linkage, including collaboration with regulators and HTA. Widely published, she is a Science and Policy Advisor to DIA and a member of the Real-World Evidence Leadership Team for ISPOR. She is a Fellow of ISPE and DIA, an Adjunct Professor of Epidemiology at University of North Carolina at Chapel Hill and a Trustee of Brandeis University.

Michael  Kelsh

Michael Kelsh

Executive Director, Research & Development, Amgen, United States

Gillis  Carrigan, PhD, MS

Gillis Carrigan, PhD, MS

Director, Center for Observational Research, Amgen, United States

Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number of settings and therapeutic areas including oncology, neuroscience, respiratory disease, and vaccine safety. In recent years, he has focused on applying epidemiological methods to real-world oncology data to augment evidence from clinical trials.

Matthew  Reynolds, PhD, FISPE

Matthew Reynolds, PhD, FISPE

Vice President, Real World Evidence, IQVIA, United States

Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research and has a deep expertise in the usage of real world data to address questions of effectiveness, safety, and value of pharmaceutical products. He founded and led the successful Database Special Interest Group for the International Society of Pharmacoepidemiology where he served as an elected executive leader. Dr. Reynolds earned his graduate and doctoral degrees in epidemiology and preventive medicine from the University of Maryland at Baltimore in January 2000.

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