How do you 'monitor' medicines?
What does the European Pharmacovigilance Risk Assessment Committee do? Sabine Straus is chairman of this committee and informs us what it is they do. She also explains the role of the European Medicines Agency (EMA).
"The most important part of my work is to identify serious side effects of medicines in time after approval, to minimize risks and to ensure that patients have and keep access to the medicines they benefit from.”
How do you do that?
"The European Pharmacovigilance Risk Assessment Committee (PRAC) monitors medicinal products and assesses whether they can continue being sold. Despite all the research prior to authorization, this is important to do because only in daily use you find out how medicines really work. We also want to know how a medicine is prescribed and which patients it is given to. So we look, for example, at whether there are side effects other than those that we already know or that known side effects occur more frequently or have more serious consequences. This is done at a European level. That is very helpful because it gives us a lot of data that we can use and analyze. Most (serious) side effects are rare. That means you need data from many patients to determine whether there is any side effect. To achieve all this, the EU countries meet once a month in the PRAC to discuss the dossiers.”
Read the sequel to the interview with Sabine Straus in which she tells more about where data about medicines comes from, why the work of EMA is important and what she thinks of the relocation of EMA to Amsterdam.