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Wednesday, June 26 • 4:15pm - 5:30pm
#391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-717-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Sudip Parikh, PhD


The New World of Post-Authorization Knowledge Building
Mary Jo Lamberti, PhD, MA

SENTINEL and Other Databases: How Are These Being Mined for Important Safety and Effectiveness Signals?
Gerald J. Dal Pan

The Potential for Real World Data/Real World Evidence to Inform Postmarketing Safety Surveillance
Jose Vega, MD

avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development
Mary Jo Lamberti leads multi-company sponsored research studies at the Tufts Center for the Study of Drug Development (CSDD). She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Sudip Parikh

Sudip Parikh

Senior Vice President and Managing Director, DIA Americas, DIA
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial... Read More →
avatar for Jose Vega

Jose Vega

Vice President, Chief Safety Officer, Merck & Co., Inc.
José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Chair of the TransCelerate Pharmacovigilance Steering Committee and as Merck's representative on the Clinical Trials... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA