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Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management
Session Chair(s)
Mitra Rocca, MSc
Associate Director, Medical Informatics, Office of Translational Science, CDER
FDA, United States
This session will discuss how large electronic health records (EHR) databases have been increasingly used by the pharmaceutical industry to support drug development and life cycle management in a variety of fields/activities such as pharmacoepidemiology, pharmacovigilance, postauthorization safety study, comparative effectiveness research, utilization pattern analysis, protocol refinement, clinical trial recruitment and cost-effectiveness assessment.
Learning Objective : Describe the significance of real-world electronic health record (EHR) data in drug development and life cycle management; Discuss learnings from implementing a scalable informatics/IT platform to support the collaborative analysis of real-world EHR data across academic/industry partners .
Speaker(s)
Manage Patient Recruitment Using Cloud Based Clinical Rules Engine
Shyam Manoj, AHIP
CitiusTech Inc., United States
Partner, Healthcare & Life Sciences
FDA Point of View
Jonathan Solomon Helfgott, MS
Stage 2 Innovations, United States
Executive Director, Global Regulatory/Clinical Affairs
Evidence from EHR about Drug Products Using the OMOP Platform
Christian G. Reich, DrMed
IQVIA, United States
Vice President, Real World Evidence Systems, IQVIA; Principal Investigator
Panelist
Jim Carroll
Inventiv Health Clinical, United States
Vice President, Product Management, Patient Outcomes
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