E1: PV Regulation 2025-2026: What Changed, What's Coming, and What You Must Do Now

What 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 episode of What's Next in PV, Tereza Korecká and Jan Kolouch sit down with Pav Rishiraj, Head of Pharmacovigilance at Celltrion and Chair of the ex-ABPI Pharmacovigilance Expert Network. After two decades across small to big pharma, Pav shares what actually surprised him in his first 100 days in a very different kind of organization. The conversation covers: Why scaling PV isn't about adding more people and process, and how systems thinking prevents unnecessary complexity What actually differs in biosimilar PV versus small molecules and novel therapeutics Why pharmacovigilance is "training rich but education poor" — and the real difference between training and competency How to build AI governance around explainability, traceability, and human-in-the-loop oversight, with lessons from a real-world system outage What "predictive safety" concretely means for case processing and signal management, beyond the buzzword What separates a strong PV specialist from someone ready to lead the function Where PV is headed in the next five years, and why ten-year predictions are not worth making yet This is a practical conversation for PV leaders, aspiring leaders, and anyone trying to figure out how much of their team's future work will still be human. Hosted by Tereza Korecká and Jan Kolouch | Guest: Pav Rishiraj, Head of Pharmacovigilance, Celltrion Keywords: pharmacovigilance, PV leadership, biosimilars, predictive safety, AI in pharmacovigilance, AI governance, human in the loop, signal detection, PSUR, competency-based leadership, systems thinking, ABPI, Celltrion

Every 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 decisions a biotech will make, and one of the most common sources of inspection findings when it is done badly. In Episode 6 of What's Next in PV, Tereza Korecka speaks with Jan Kolouch and Vojtech Kvita from NextPV Services about how to approach the safety database decision end to end: What a safety database actually does inside the PV system, and when a company can function without one How vendor choice depends on ICSR volume, functionality, region, and budget — not just brand name Build vs. buy vs. outsource: control, cost, and who really owns your data in each model What GAMP 5 and EU Annex 11 validation actually requires: URS, IQ/OQ/PQ, and change control Practical setup steps: dictionaries, workflows, SOPs, and EudraVigilance gateway testing What triggers a database migration, and why it is one of the most error-prone PV projects Why due diligence, not the vendor's brand, determines whether the system holds up at inspection This is a practical conversation for PV, QA, IT, and biotech leaders selecting, validating, or migrating a safety database. Hosted by Tereza Korecka | Guests: Jan Kolouch and Vojtech Kvita, NextPV Services (00:00) - Intro music and episode introduction(00:31) - Opening and guest greetings(00:41) - Today's topic: safety databases(00:58) - What a safety database does inside the PV system(02:16) - Do you actually need one? Volume, PSURs, and reporting obligations(03:26) - Overview question: which vendors do companies choose from(03:51) - Main selection factors: volume, functionality, region, and budget(07:45) - Large vs. small organizations: enhanced functionality vs. practicality(11:26) - Build, buy, or outsource: framing the decision(11:59) - The build option, database ownership, and vendor-managed models(16:46) - Why building your own database is rare in practice today(18:21) - GAMP validation: what the process actually looks like(19:00) - URS, FS, IQ/OQ/PQ, GAMP 5, EU Annex 11, and the EU AI Act(23:21) - Beyond validation: what companies trip up on at setup(23:52) - Database setup: dictionaries, workflows, SOPs, and EudraVigilance gateway testing(29:22) - Changing databases: what actually triggers a migration(29:46) - Migration scenarios: E2B exports, script migration, and data enrichment(34:27) - When migrations slip: deviations, mitigation, and inspections(36:54) - Closing advice for biotechs facing a database decision(37:34) - Operating model, timeline buffers, and post-launch monitoring(42:18) - Due diligence as the thread through the whole process(45:23) - Migration usually happens alongside the day job(46:20) - Why it helps to have an internal database point person(47:33) - Closing remarks

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 should approach computerized systems as strategic infrastructure, not just software. The conversation covers: What makes a tool relevant for pharmacovigilance and GxP work Why companies should start with process, data flow, and intended use before vendor demos Strategic routes: current vendor modules, new vendors, integrations, APIs, and internal builds How scorecards, sandbox testing, and business requirements help decision makers Why cost should be assessed beyond licence price What validation means for configurable and cloud-based tools Where AI fits, and why automation and audit trails still matter How the approach differs for small biotechs and large pharma companies This is a practical episode for PV, QA, IT, regulatory, and biotech leaders reviewing their technology stack or preparing for a regulated tool selection project. Hosted by Tereza Korecka | Guests: Jan Kolouch and Vojtech Kvita, NextPV Services Keywords: pharmacovigilance, computerized systems, computerized tools, PV systems, GxP validation, safety database, PV technology, AI in pharmacovigilance, automation, audit trail, data integrity, PSMF, QMS, vendor selection, biotech PV

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, including: What medical writing covers in pharmacovigilance, from case narratives to aggregate reports and risk management documents Why aggregate reports depend on signal detection, risk minimisation, case collection, exposure data, regulatory input, and source-data quality Where DSURs, RMPs, PSURs/PBRERs, and addenda to clinical overviews appear across the product lifecycle Why teams underestimate timelines, review cycles, and cross-functional coordination Common quality issues such as inconsistent data, outdated content, and late submissions What works, and what breaks, when medical writing is outsourced How a small biotech should start planning its first major PV document This is a practical conversation for PV teams, regulatory teams, and biotech leaders who want documents that are not only submission-ready, but defensible. Hosted by Tereza Korecka | Guests: Katarina Cechlovska and Hana Sourkova, NextPV Services

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