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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

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.
      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

      Common Data Models: Implementation and Use

      Jeffrey Brown, PhD, MA

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

      Industry Perspective

      Christian G. Reich

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