What's Next in PV

Choosing a PV tool is no longer just a safety database decision. Computerized systems now sit across pharmacovigilance operations: safety databases, PSMF tools, QMS platforms, reporting layers, integrations, dashboards, automation, and AI-enabled capabilities. In Episode 5 of What's Next in PV, Tereza Korecka speaks with Jan Kolouch and Vojtech Kvita from NextPV Services about how PV teams sho...

Medical writing in pharmacovigilance is not just writing. It is the point where safety data, process outputs, cross-functional input, and benefit-risk judgement come together into a document regulators can evaluate. In Episode 4 of What's Next in PV, Tereza Korecka speaks with Katarina Cechlovska and Hana Sourkova from NextPV Services about what strong PV medical writing actually requires, inc...

If your biotech is planning EU market entry, MAA readiness in pharmacovigilance means more than assembling a document package. In Episode 3 of What's Next in PV, Tereza Korecka speaks with Jan Kolouch and Vojtech Kvita from NextPV Services about what needs to be in place before MAA submission, including: Why MAA readiness should be treated as a functioning, auditable PV system When to start bu...

In Episode 2 of What's Next in PV, Tereza Korecka sits down with Vojtech Kvita and Josue Vazquez from NextPV Services to break down exactly what audit readiness looks like in 2026 - under the expanded requirements of EU Regulation 2025/1466 and heightened regulatory expectations worldwide. It's a practitioner-to-practitioner conversation on what actually works, what adds real value, and wh...

In this episode of What's Next in PV, co-founders Jan and Vojtech sit downto break down exactly what EU Regulation 2025/1466 means for marketingauthorization holders, biotech companies, and PV professionals navigating the2025-2026 regulatory wave. Key topics covered: - Signal management overhaul: Why standalone signal notifications have been eliminated, and what "EudraVigilance monitoring...