What's Next in PV

NextPV Services, s.r.o.

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.

Puntate

  1. 10 FEB

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

    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 in parallel" actually requires - EVDAS mandate: The end of the pilot program, how to decide at which stage of your signal management processto use EVDAS, and why the reference period timing matters - Third-party auditing requirements: New subcontracting rules, contract clauses that now need updating, and how audit scope has expanded - GVP module revision wave: Which modules are being updated in Q1-Q4 2026 - Inspection readiness: Practical steps to take now, whether your organization is small and agile or large and complex   TIMESTAMPS: (00:00) - Intro and episode overview (00:46) - Why 2025-2026 is a pivotal moment for PV regulation (context setting) (01:13) - EU Regulation 2025/1466: The first major overhaul since 2012 (02:25) - Topic 1: Signal management - what has changed and why it matters (03:22) - History of EudraVigilance and the EVDAS pilot program (2017-2025) (05:22) - End of the EVDAS pilot: what mandatory "monitoring in parallel" actually means (06:09) - How MAHs can decide at which stage of signal management to use EVDAS(07:30) - Risk assessment before deciding your EVDAS strategy(08:03) - Why standalone signal notifications were eliminated(09:07) - Practical implications: how signals are now communicated to authorities(11:13) - PSUR vs. non-PSUR holders: who is affected and how(12:53) - Monitoring PRAC and meeting minutes as part of your signal management(14:08) - Why MAH and regulator EVDAS views differ - and what this means in practice (15:36) - EVDAS deep dive: ERMR, line listings, and the three core functionalities (17:26) - Reference periods explained: 15-day, 1-month, 3-month, 6-month, 1-year (19:07) - The fixed period trap: why you cannot run EVDAS retrospectively (21:08) - How to determine the right monitoring frequency for your portfolio (22:11) - Topic 2: Third-party and auditing - new requirements under Regulation2025/1466 (22:36) - Subcontracting rules: MAH consent now required for further delegation (23:45) - Practical contract guidance: MSA vs. SOW - where to include new clauses(24:55) - All subcontracted PV activities must now be included in audits (25:21) - A candid conversation: are audits always adding value? (27:09) - How to run audits that find real risk, not just checkbox findings (28:14) - What good audit strategy actually looks like (30:40) - Topic 3: GVP module updates coming in 2026 - the full picture (31:18) - GVP Module 9 (Signal Management): what to expect and when (32:06) - GVP Modules 5, 6, and addendums: scope of changes (33:22) - How organizations of different sizes should manage the update wave (35:17) - Should companies wait for Module 9 before updating SOPs? (36:01) - Deviation-based approach vs. full SOP update - which is right for your org?(38:14) - Practical implementation: memos to file, signal detection plans, and interim steps (39:12) - The "no less frequent than 6 months" clause being removed from Module 9(40:03) - Topic 4: What companies should do to be inspection-ready right now(40:18) - The two implementation deadlines: August 12, 2025 and February 12, 2026(41:40) - PSMF updates: deviations, wording changes, and what to check in your templates(42:11) - A message for overwhelmed teams: how to start when everything feels urgent(43:42) - Closing thoughts from Jan: planning for the wave of changes ahead(44:44) - Note on non-EU organizations: why context matters when communicating changes internally(45:14) - Closing thoughts from Vojtech: SOP interdependency and getting it right the first time(47:07) - Sign-off and next episode preview

    47 min
  • 1 puntata

Descrizione

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.

Informazioni

  • Creatore
    NextPV Services, s.r.o.
  • Anni di attività
    2026
  • Puntate
    1
  • Classificazione
    Contenuti adatti a tutti
  • Copyright
    © NextPV Services, s.r.o.
  • Sito web del podcast
    What's Next in PV