Development of a Standard Report for Signal Verification on Public Adverse Event Databases

Publically available external pharmacovigilance databases, such as the American FDA’s Adverse Event Reporting System (AERS) and the VigiBase database of the Uppsala Monitoring Centre (UMC), are currently not obligatorily taken into account by the pharmaceutical product manufacturers regarding potential drug safety signals. The value of this information on adverse events that is revealed in these databases is well acknowledged by product experts. These external data sources are now being evaluated for their suitability to at least support sign ...