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Tuesday, June 26 • 10:30am - 11:45am
#230: Common Data Model Harmonization for Evidence Generation

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss how to use real-world data to support evidence generation for regulatory and clinical decision making.


Mitra Rocca, MSc


Unlocking Real-World Value from EHRs: FDA's Harmonization of CDMs for Real World Evidence
Michael A. Ibara, PharmD

Common Data Models: Implementation and Use
Jeffrey Brown, PhD, MA

Industry Perspective
Christian G. Reich, DrMed


Jeffrey Brown

Associate Professor, Department of Population Medicine, Harvard Pilgrim Health Care Institute/Harvard Medical School
Dr. Brown is an Associate Professor in the Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute. His primary research activities involve new approaches to facilitate large-scale multi-institutional research and the use of distributed... Read More →
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →

Christian Reich

Vice President, Real World Evidence Systems, IQVIA; Principal Investigator, IQVIA
Christian Reich is VP, Real World Insights at IQVIA, leading a team offering standardized analytics across a large global network of observational data. He is also Principal Investigator at the OHDSI collaborative, which focuses on creating comprehensive evidence about disease, healthcare... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Session