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DIA 2018 Global Annual Meeting


Common Data Model Harmonization for Evidence Generation

    Session Chair(s)
      Mitra  Rocca, MSc

      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 : Describe the FDA harmonization project of common data models; Describe the EHR use case demonstration as part of the FDA commond data model project; Understand the challenges and solutions involved in demonstrating this use case.
    Speaker(s)
      Michael A. Ibara, PharmD

      Unlocking Real-World Value from EHRs: FDA's Harmonization of CDMs for Real World Evidence

      Michael A. Ibara, PharmD

      • Head of Digital Healthcare
      • Michael Ibara Consulting, United States
      Jeffrey  Brown, PhD, MA

      To be determined

      Jeffrey Brown, PhD, MA

      • Associate Professor, Department of Population Medicine
      • Harvard Pilgrim Health Care Institute/Harvard Medical School, United States
      Christian G. Reich

      To be determined

      Christian G. Reich

      • Vice President, Real World Evdience Systems, IQVIA; Principal Investigator
      • Observational Health Data Sciences and Informatics (OHDSI), United States