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Risk Management

Risk management plans anchor EU and global pharmacovigilance strategy. Monitor guidance and enforcement that affects RMP content, risk minimisation activities, post-authorisation safety studies (PASS), and cross-functional alignment between QPPV oversight, medical safety, and regulatory intelligence teams.

3 updates · Sorted by impact priority

publicTga · Australia · Updated May 22, 2026

TGA safety updates add warnings for GLP-1s, fluoroquinolones, RSV vaccines

Urgency: Medium

Tga update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

Label GovernanceSignal ValidationLocal Safety Officer

SOP Impact6 SOPs

ConfidenceMedium

Relevant for: Local Safety Officer, Signal Management Lead, Labeling Lead

verifiedRegulatory action: Regulators

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publicUpdated May 21, 2026

WSJ: Japan adds new warnings for Amgen’s Tavneos after deaths

Urgency: Medium

This update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

Label GovernanceSignal ValidationSignal Management Lead

SOP Impact5 SOPs

ConfidenceMedium

Relevant for: Signal Management Lead, Labeling Lead, PV Technology / CSV Lead

verifiedRegulatory action: Latest

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publicEma · Updated May 21, 2026

MaaT Pharma flags CHMP “negative trend” ahead of June vote

Urgency: Medium

Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.

Label GovernanceRisk ManagementSignal Management Lead

SOP Impact5 SOPs

ConfidenceMedium

Relevant for: Signal Management Lead, Labeling Lead, Regulatory Intelligence Lead

verifiedRegulatory action: Latest

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