17th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

This virtual meeting aimed to inform, get feedback and foster dialogue between industry and the EU regulators.

Topics included:

• adherence to PRAC recommendations for PSURs’ of Nationally Authorised Products,
• update on Good Pharmacovigilance Practices (EU-GVP),
• PRAC Impact Strategy (Rev. 2) and impact research projects,
• access of the off-patent sector to additional Risk Minimisation Measures,
• follow up questionnaires of the reference products,
• PSUR frequencies for active substances with Data Lock Point 2025 based on a risk-based approach, and
• update on PASSes.