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Tuesday, June 20 • 4:00pm - 5:00pm
#268: FDA Session: Health IT at FDA

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will focus on the status of health informatics at the FDA. Topics will include data standards for health care and clinical research, as well as use of EDC and EHRs in clinical research.

Learning Objectives

Explain the Health IT activities at the FDA; Discuss the use of Health IT systems in clinical research; Discuss the results of one of the FDA-led initiatives focusing on the use of EHRs and other types of eSource in clinical investigations.

Chair

Mitra Rocca, MSc

Speaker

Health Information Technology at FDA
Mitra Rocca, MSc

Structured Sourcing of Clinical Data from EHRs
Adam L Asare, PhD



Speakers
avatar for Adam Asare

Adam Asare

Chief Data Officer, Quantum Leap Healthcare Collaborative
Adam Asare has over 15 years’ experience in academic and industry developing clinical and research information systems. He recently joined Quantum Leap Healthcare Collaborative where he oversees efforts for process re-engineering for quality improvement of clinical trials and r... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
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 join... Read More →


Tuesday June 20, 2017 4:00pm - 5:00pm
N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616