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Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management
Program Code:
273
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Mitra Rocca,
MS (SCHAGY), Senior Medical Informatician, 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 and standards for the Sentinel System. Prior to joining the FDA, Mitra served as the Associate Director, Health care Informatics at Novartis Pharmaceuticals Corporation.
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SPEAKER
(S):
Shyam Manoj is a Senior Healthcare Informatics Consultant at CitiusTech. He is a domain expert in Healthcare Business Intelligence, Clinical Quality Reporting & Analytics, Meaningful use compliance, Clinical Trials, REMS, Patient Recruitment Strategies and Healthcare Interoperability.
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Prior to joining CDER Jonathan worked at CDRH BIMO and co-developed the Software Education Program. Jonathan specializes in Computerized Systems used in FDA regulated Clinical Investigations. Jonathan holds an MS in Bioscience Reg. Affairs from Johns Hopkins & BS from UMCP in Cell Biology & Genetics
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Jim Carroll, (SPKNON), Inventiv Health Clinical, United States
Christian G. Reich, (SPKNON), AstraZeneca, United States
Description
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.