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Wednesday, June 21 • 4:00pm - 5:15pm
#363: EHRs/eSource and Emerging Data Streams

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will discuss the convergence of clinical trials with clinical practice – bringing all the data together to use to identify new questions and answers.

Learning Objectives

Discuss the potential and complexities associated with EHR to EDC data transfer.


Mitra Rocca, MSc


TransCelerate and HL-7 Opportunities in the World of eSource
Julian M. Jenkins

HL7 Based EHR Storage SS-MIX2 and Applications from Local Case Cards to Nationwide Adverse Event Detection
Michio Kimura, MD, PhD

eSource and Building the Learning Healthcare System
Michael A. Ibara, PharmD

Unlocking the Value of Electronic Health Record Data in Clinical Research
Lisa Amanti, JD


Lisa Amanti

Associate General Counsel, athenahealth
Lisa Amanti is the Associate General Counsel Director at athenahealth. In this role, she is responsible for informing and overseeing the use of athena’s data and it’s network effect, with an increasing focus on bridging the divide between clinical practice and clinical research... 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 →

Julian Jenkins

Vice President, Innovation Performance and Technology, GlaxoSmithKline
Dr. Julian Jenkins is VP ad head of Innovation, Performance and Technology at GSK R&D, which involves maintaining a state of the art clinical technology infrastructure and the innovation agenda for clinical research. He is also GSK’s representative on the TransCelerate oversight... Read More →

Michio Kimura

Professor and Director, Department of Medical Informatics, Hamamatsu University School of Medicine
MD, Osaka University, 1986, PhD in Radiology, Tokyo University, 1990, FACMI 2014. 1992-present, Hamamatsu University Hospital, Director of Medical Informatics Department JAMI ex-president, IMIA vice president HL7 Japan Chair, IHE International Board
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 →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  01: Data-BigData-eHealth, Forum