In an industry where CEOs often talk about “AI in Pharmacovigilance” at conferences, yet their operations largely rely on manual processes, we saw an opportunity for genuine innovation. Last year, Tepsivo successfully implemented AI into our PV Software and we are happy to share our learnings.

The European legislation for performing pharmacovigilance activities, Implementing Regulation (EU) No 520/2012, is likely to be amended during 2025. Here’s an overview of the amendments to learn what changes for pharmaceutical companies this update would bring.

In this blog post, we’ll look into the EU legal text related to GVP and compare it to the other pharmaceutical Good “Something” Practices – what are the legal requirements related to these guidelines and how they are described in the related legislation.

We have written this comprehensive summary of RegulatoryConnect capabilities in order to provide a quick overview of the new(ish) system to anyone who is interested in what the portal is about, and how you can start using it.