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