How UMC detects signals

UMC regularly screens VigiBase, WHO's global database of reported side effects of medicinal products, to look for previously unrecognised or incompletely documented suspected side effects. With millions of adverse event reports in VigiBase, signal detection at UMC relies on a combination of computerised data mining methodology and clinical evaluation of reports for the prioritisation of medicine–adverse effect combinations. In parallel, qualitative screening of scientific literature provides additional insight to perform more targeted searches in VigiLyze (our signal detection and management system) and determine if additional investigation into potential safety signals is needed. Regular monitoring of international regulators’ activities and close collaboration with our external clinical expert group is also used to detect arising safety concerns and helps to avoid repetition of signal work between organisations.

Selected medicine-adverse effect combinations are individually assessed by our signal team to identify medicine-adverse effect combinations needing further in-depth assessment. The initial assessment consists of checking whether the adverse effect is already adequately covered in the product information, excluding other more likely causes, and deciding on whether the combination should be further assessed.