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What's Next in PV
by NextPV Services, s.r.o.
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Latest episodes
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E7: Pav Rishiraj - Are We Training PV People, or Educating Them?
October 1, 2026 · 57 minWhat changes when a pharmacovigilance leader moves from a mature, legacy-heavy portfolio to a young, fast-growing one — and what does PV leadership actually look like once you strip away the checklists? In this milestone first-guest…
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E6: Safety Databases in Pharmacovigilance: Selection, Validation, and Migration
July 21, 2026 · 49 minEvery pharmacovigilance system runs on a safety database — the central engine where every ICSR is entered, processed, and reported. But choosing, validating, and maintaining that database is one of the most consequential infrastructure…
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E5: Computerized Systems in Pharmacovigilance: How to Choose, Validate, and Operate the Right Tools
May 26, 2026 · 47 minChoosing 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…
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E4: Medical Writing in Pharmacovigilance: DSUR, PSUR, RMP, and Benefit-Risk Documents
April 7, 2026 · 26 minMedical 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…
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E3: EU MAA Pharmacovigilance Readiness: Operating Model, QPPV, and Submission Preparation
March 24, 2026 · 43 minIf 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…
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E2: PV Audit Readiness 2026 - Types of Audits, Gap Analysis, and Your Inspection Survival Guide
February 27, 2026 · 57 minIn 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…
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E1: PV Regulation 2025-2026: What Changed, What's Coming, and What You Must Do Now
February 10, 2026 · 47 minIn 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…
About the show
Podcast that will take your drug safety to the #NextLevel.
Pharmacovigilance is a complex science, but it should not be complicated. We at NextPV want to bring you insights and knowledge through our conversations. We will cover everything from big strategic topics to smaller operational ones and current news. Welcome and enjoy listening.