Pharmacovigilance departments must keep track of all news related to a particular medicine. 

PRAC* recommendations on safety signals are one of the most important sources. 

Usually, people responsible for pharmacovigilance keep a long list of websites they track, to ensure they are on top of the latest news. One of the most important is the website of the European Medicines Agency (EMA). But it can be a bit of a maze. 

That’s not surprising, since its scope is huge. EMA tries to make life easier, by updating a What’s new section, where they list all the updates they make. What’s new | European Medicines Agency (EMA) 

This is a great resource to make sure we’re on top of things. But there’s a danger that we miss a link and the news goes unnoticed. 

To avoid this problem, it is helpful to create a list of the definitive pages. These are pages where the final and latest versions of documents live. 

While there are many such pages, few are as important as the one listing all PRAC safety signal recommendations. You can find the page here: PRAC recommendations on safety signals | European Medicines Agency (EMA) 

PRAC recommendations often trigger variations. So it is crucial to detect them on time. 

The fastest way to see the recommendations is to check the meeting agendas and minutes. But those files contain a lot of other information. So there’s once again the risk of missing something. 

While this site is the last in line to receive updates, it is the definitive place where all signal related variations are published. If you regularly check it, you won’t miss anything important. 

If it is not yet in your collection, we recommend you add it to your list of pages to monitor. 

That way you never have to worry about missing a PRAC safety signal variation. 

PRAC = Pharmacovigilance Risk Assessment Committee