Anyone working in pharmacovigilance (PV) will already have spent many months working their way through the ever changing updates and reforms to the Risk Management Plan (RMP), and the newly legislated RMP summary. Those not working in PV will probably also have heard all about it (if only through the tortured wails of their PV colleagues!). To everyone’s delight and amazement, we survived the pilot phase; consultation comments have been received and a new and improved version is imminent. We all eagerly await the revision of the RMP summary in particular: will the original concerns be addressed? Will we still be asked to produce a single document that can satisfy both professional healthcare providers and the general public in one fell swoop? Will the RMP summary achieve its aim of increasing transparency for the lay audience?? We will find out in time, I’m sure. But in the meantime, I’m delighted to present to you a really excellent article from Tizianavon Bruchhausen and Stefanie Rechtsteiner. Tiziana and Stefanie chart beautifully the evolution of, and challenges posed, conquered, and still to be undertaken, by the RMP summary guidance. This article really should be called ‘Everything you wanted to know about the RMP summary but were afraid to ask‘ and I will be printing it out and pinning it to my wall!
You must be a member of EMWA in order to download the full article.
EMWA members please log in to download the full article.
If you would like to become a member of EMWA, please join here.