PV Bulletin

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Search published pharmacovigilance and regulatory intelligence briefings by regulator, product, workflow, QPPV topic, or safety signal.

Found 2 result(s) for "ANSM".

Showing 1-2 of 2 published article match(es)

publicANSM (France) · France · Updated Sep 16, 2026Translated from French

Safety Signal Management Updates for RSV Bronchiolitis Treatments in France

Awareness · Medium

PV teams need to update Standard Operating Procedures (SOPs) for Signal Management to include enhanced monitoring guidelines for medication errors specifically related to RSV treatments. Additionally, teams should ensure proper communication of these updates to healthcare professionals involved in patient care.

Signal ManagementLiterature SurveillanceSignal Management Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Signal Management Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
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publicANSM (France) · France · Updated Sep 16, 2026Translated from French

Update on PRAC Outcomes Affecting Injectable Iron Medicines

Awareness · Medium

Pharmacovigilance teams must update signal management processes to incorporate the new monitoring guidelines for injectable iron medicines. This includes reviewing current risk assessment processes and potentially updating medication guidelines to ensure compliance with the new recommendations.

Signal ManagementInspection ReadinessRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Regulators
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