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

• Date:
  Monday, 07 November 2022, 09:00 - 12:30 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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.

Documents

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

Reference Number: EMA/855037/2022

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

Presentation - Update on PRAC Impact Strategy (Rev. 2) and impact research projects (T.Goedecke, EMA)

Presentation - PSUR frequencies for active substances with DLP 2025 based on a risk-based approach (M.Lopez Fauqued, GPAG)

Presentation - International transfer of personal (health) data in ICSRs originating from EudraVigilance (S.Brosch, EMA)

Presentation - Good Pharmacovigilance Practices (EU-GVP) - Update (P.Bahri, EMA)