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Common Data Model Harmonization for Evidence Generation
Session Chair(s)
Mitra Rocca, MSc
Associate Director, Medical Informatics, Office of Translational Science, CDER
FDA, United States
This session will discuss how to facilitate the use of real-world data (RWD) sources (e.g., claims, EHRs, registries, electronic patient-reported outcomes (ePRO) to support evidence generation for regulatory and clinical decision making.
Learning Objective : Discuss how to use real-world data to support evidence generation for regulatory and clinical decision making.
Speaker(s)
Unlocking Real-World Value from EHRs: FDA's Harmonization of CDMs for Real World Evidence
Michael A. Ibara, PharmD
Elligo Health Research, United States
Chief Data Officer
Common Data Models: Implementation and Use
Jeffrey Brown, PhD, MA
Harvard Pilgrim Health Care Institute/Harvard Medical School, United States
Associate Professor, Department of Population Medicine
Industry Perspective
Christian G. Reich, DrMed
IQVIA, United States
Vice President, Real World Evidence Systems, IQVIA; Principal Investigator
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