The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Common Data Model Harmonization for Evidence Generation
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.
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
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
Vice President, Real World Evidence Systems, IQVIA; Principal Investigator
Observational Health Data Sciences and Informatics (OHDSI), United States