DIA EUROPE 2020

Despite enormous technological advances, data driven pharmacovigilance has not at its core changed much since the 1960s. Changes are afoot. Pharmacovigilance is becoming more of a multiple data stream discipline requiring consideration of multiple types of data such as ICSRs, electronic medical records (EMRs) and social media and other user generated content. In addition more than ever before multiple data sets of the same type of data e.g. in spontaneous reports – Vigibase, EVDAS, FAERS, literature and company internal databases are available with increasing, and varying, analysis possibilities and sometimes requirements: While this provides opportunities, different instances or versions of data sources, access approaches as well as analytic strategies can all lead to differences in analysis outputs and the potential to obfuscate, rather than enhance PV processes. The session will provide an overview of how PV has changed and the opportunities for further progress, a discussion of approaches in accessing and analysing EVDAS and how this can lead to unwanted divergence in outputs; lastly an example on how technological advances can better enable adverse event reporting.