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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, MPH, FISPE

Nancy Dreyer, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness and natural history research, using diverse forms of data including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration. She is a Fellow of International Society of Pharmacoepidemiology (ISPE) and of DIA, and is a Science and Policy Advisor to DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and a member of ISPOR's RWE Leadership Team.

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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