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Big and MultiStream Data for Drug Evaluation: The Promise and Cautions
Session Chair(s)
Mark Levenson, PhD
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
FDA, United States
This forum will discuss current and emerging large and multistream data sources for drug evaluation and the associated methods and systems. It will also highlight the promises and cautions of the data sources.
Learning Objective : Describe current and emerging data sources, and associated method and systems for postmarket drug evaluation; Discuss the potential and the cautions in the use of current and emerging data.
Speaker(s)
Establishing an Open-Source Community for Large-Scale Analytics and International Evidence Generation: Lessons from the Observational Health Data Sciences and Informatics Program
Patrick Ryan
Janssen Pharmaceuticals, Inc., United States
Head, Epidemiology Analytics
FDA Active Postmarketing Drug Safety Surveillance: Mini-Sentinel to Sentinel, Current and Emerging Capabilities
Marsha E. Reichman, PhD
FDA, United States
Sr. Advisor/Scientific Lead Surveillance Programs, Sentinel Initative Lead, CDER
Big Data and Safety Surveillance: Are We Building a Bigger Haystack?
Susan Gruber, PhD, MPH, MS
Reagan-Udall Foundation for the FDA, United States
Senior Director, IMEDS-Methods Research
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Ways to register
Registration override should work.