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Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will be an interactive FDA panel focused on eClinical and eHealth tools and guidance to enhance regulatory science and expedite drug development. The audience will actively participate throughout the session.
Learning Objective : List FDASIA/PDUFA V commitments related to electronic study data standards; Discuss the eSource guidance and its impact on EDC and EHRs; Summarize the status of various FDA initiatives focused on EHRs and study data and therapeutic area standards.
Speaker(s)
Panelist
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Panelist
Mitra Rocca, MSc
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
Panelist
Jonathan Solomon Helfgott, MS
Stage 2 Innovations, United States
Executive Director, Global Regulatory/Clinical Affairs
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