Supporting national pharmacovigilance centres’ quantitative and qualitative signal detection processes on national, regional and global levels.
By putting a lot of effort into coding and structuring the VigiBase information, UMC makes it possible to search and analyse the data. With VigiLyze, national centres can take advantage of the scientific advancements that UMC makes in the area of pharmacovigilance.
VigiLyze is a signal detection and management system that can use national, regional or global data as the starting point for quantitative signal detection. It provides support for the entire signal management process, including the qualitative assessments. Major strengths include its capacity to recalculate disproportionality based on any chosen country or region background within seconds, and the easily available related investigations that for any given search based on drug or reaction will provide related signals shared with the programme from UMC, other national centres – or the own centres ongoing or finalised assessments.
VigiLyze is available free of charge to national pharmacovigilance centres in all member countries of the WHO Programme for International Drug Monitoring. Under-reporting is a known issue in pharmacovigilance. By sharing national reports of adverse events to the global database, individual countries can help increase all countries' understanding of possible safety concerns.
VigiLyze provides a national, regional, and global view of the suspected adverse effects of a medicine. This huge collection of data supports assessments of emerging domestic issues. Through VigiLyze you have easy access to post-marketing safety information for drugs that are new to your national market, but that are marketed in other parts of the world.
UMC has created a guidance on how to find adverse event reports linked to COVID-19 treatments in VigiLyze.
VigiLyze enables quantitative signal detection on national, regional or global data, and lets you manage signals, document your own assessments, and read UMC’s and other NCs' signals.
VigiLyze supports the entire signal detection and management process with the ability to assign and document your work within the system. It is easy to connect an assessment to drug and reaction and it will show up as a related investigation when searching for the same (or similar) drugs and reactions in the future. This minimizes the risk of doing the same assessment again when an issue remerges. You can even upload documents, like signal check lists, templates or supporting references to your investigation. After finalising a signal assessment, the result is easy to share with the WHO PIDM community in VigiLyze and will then show up as a related investigation when they search for similar drugs and reactions.
VigiLyze instantly provides overview graphs, case line listings and disproportionality calculations for national data, but the global view is either side-by-side or only one click away.
Disproportionality calculations are based on the country/region background as selected by the user (default is my country). This background can easily be changed and does not require time consuming ‘data mining’ runs, it will recalculate in seconds based on the user’s choice.
If you have questions about VigiLyze, contact us.