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The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes
Session Chair(s)
Gregory Daniel, PHD, MPH
Vice President, Head of Public Policy Innovation and Evidence
Eli Lilly and Company, United States
This session will clarify the growth of big data assets both in the private and public sector, the tools that can be used to evaluate drug real world safety and effectiveness, and the increasingly favorable view of big data by regulators as a more comprehensive and less expensive approach to postapproval monitoring for safety and effectiveness.
Learning Objective : Explain use of data postapproval.
Speaker(s)
Industry Perspective
Gracie Lieberman, MS
Genentech, United States
Executive Director of Regulatory Policy
PCORI Perspective
Joe V. Selby, DrMed, MPH
Patient-Centered Outcomes Research Institute (PCORI), United States
Founding Executive Director
Fulfilling the Vision of Sentinel as a National Resource: Public Access Through the Reagan-Udall Foundation for the FDA
David Martin, MD, MPH
Novartis, United States
Vice President, Head, PCO Center of Excellence