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 building readiness and why 12-18 months is the preferred window
• How to think about operating model, vendor setup, and safety database decisions
• What an effective QPPV setup looks like before submission
• What inputs are needed to build a usable PSMF
• How to approach RMP readiness, including the value of a development RMP
• What to prioritize next week if your timeline is already tight

This is a practical conversation for biotech teams moving from clinical development toward EU commercialization and trying to build a submission-ready PV system without unnecessary chaos.

Keywords: pharmacovigilance, MAA readiness, EU market entry, biotech, QPPV, PSMF, RMP, safety database, vendor oversight, PV system, marketing authorization application, EU submission

(00:00) Intro and episode overview(00:58) What MA readiness means for biotech companies entering the EU(06:35) Is BLA timing enough, or should teams start earlier?(12:53) Practical MAA prep timeline and the 12-18 month window(15:48) First decisions: operating model, vendors, and safety database ownership(21:20) What an effective QPPV setup looks like before MAA(26:47) Building and maintaining the PSMF(32:01) How to prepare a strong RMP and why a development RMP helps(37:38) What to do next week if you are already behind on MAA readiness(42:51) Wrap-up and closing