18th industry stakeholder platform - operation of European Union (EU) pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 November 2023, 13:00 (CET) to 22 November 2023, 16:30 (CET)
This virtual meeting aimed to inform, get feedback and foster dialogue between industry and the EU regulators.
Topics included:
- artificial intelligence in pharmacovigilance;
- update on good pharmacovigilance practice;
- risk management plans, including EMA transparency measures and guideline on specific adverse reaction follow-up questionnaires;
- updates on PASS with the catalogues to replace the current ENCePP resources database, and the EU PAS register
- EudraVigilance update.
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