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AI in Pharmacovigilance: Adverse Event Monitoring and Regulatory Compliance

Discover how AI transforms pharmacovigilance: adverse event monitoring with NLP, automatic AIFA/EMA reporting, and digital audit trail for MDR/IVDR compliance.

IL DOGE DI VENEZIA·9 Apr 2026·10 min read

AI in pharmacovigilance automates adverse event monitoring, signal classification, and periodic report generation (PSUR). Reduces reporting time by 50-70% and ensures EMA/AIFA compliance. Critical for pharmaceutical SMEs with limited resources.

This is an abridged translation. For the full content, please refer to the Italian version.

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