Post-market Drug Safety Monitoring in the Age of Big Data
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*Robert Ball, FDA/CDER 

Keywords: pharmacovigilance, observational data, pharmacoepidemiology

This talk will provide an overview of the types of Big Data FDA CDER uses for post-market drug safety monitoring and the need for careful selection of analysis methods based on these data sources. The talk will also touch on new Big Data streams being evaluated and their potential roles in post-market drug safety monitoring.