By Mei Sheng Duh, Brian Ellman, Marc Van Audenrode, Paul E. Greenberg and Pierre Y. Cremieux; Analysis Group, Inc. Law360, New York (May 23, 2017, 10:29 AM EDT) Learning From Social Media For Adverse Event Reporting Those interested in monitoring drug safety in the post-marketing seting have been exploring how best to capitalize on the vast amount of information available through social media platforms. While recent studies have suggested that social media may pro- vide a useful source of additional information on patients’ experiences afer exposure to pharmaceutical and biotechnology products, they also highlight serious limitations on the use and interpretation of such data. As researchers continue to develop tools and methods to analyze social media data, it becomes necessary to consider how best to use those data and, perhaps more importantly, limitations to their uses in identifying and evaluating drug-induced adverse events (“AEs”). Using Spontaneous Reporting Systems to Report Adverse Events Pharmacovigilance is the science of detecting and assessing the efects of marketed drugs post-regulatory trials and U.S. Food and Drug Administration approval. Ongoing monitoring is needed to identify and collect data on AEs that may not have surfaced in the tightly controlled environment of a clinical trial. Pharmacovigilance principally involves identifying and evaluating safety signals using data sources that are ofen referred to as “numerator-based,” such as spontaneous adverse event reports and case Mei Sheng Duh Brian Elman Marc van Audenrode Paul E. Greenberg Pierre Y. Cremieux