戻る Agenda
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
Chief Data Officer, Elligo Health Research, 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
Industry Perspective
Christian G. Reich, DrMed
Chief Science Officer , Nemesis Health , United States