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Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies
Session Chair(s)
Sudip Parikh, PhD
Senior Vice President and Managing Director, DIA Americas
DIA, United States
This forum will discuss SENTINEL and other databases and how they are being mined for important signals. How is AI being used to assess real world effectiveness? Can AI inform a risk-based approach to lifecycle management?
Learning Objective : Discuss how Sentinel and other databases are being mined for important signals; Identify how real work evidence and artificial intelligence is being used to inform post-authorization activities; Identify if artifical intelligence is a risk-based approach to lifecycle management.
Speaker(s)
The New World of Post-Authorization Knowledge Building
Mary Jo Lamberti, PhD, MA
Tufts Center for the Study of Drug Development, United States
Director of Sponsored Research, Research Associate Professor
SENTINEL and Other Databases: How Are These Being Mined for Important Safety and Effectiveness Signals?
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
The Potential for Real World Data/Real World Evidence to Inform Postmarketing Safety Surveillance
Jose Vega, MD
Moderna, United States
Chief Safety Officer
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