17th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
Table of contents
Date:
07/11/2022
Location:
Online, 09:00 - 12:30 Amsterdam time (CET)
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.
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Agenda - 17th industry stakeholder platform - operation of European Union (EU) pharmacovigilance (PDF/186.68 KB)
First published: 30/11/2022
EMA/855037/2022 -
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Highlights - 17th industry stakeholder platform - operation of European Union (EU) pharmacovigilance (PDF/204.3 KB)
First published: 30/11/2022 -
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Presentation - Update on PRAC Impact Strategy (Rev. 2) and impact research projects (T.Goedecke, EMA) (PDF/547.44 KB)
First published: 30/11/2022 -
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Presentation - PSUR frequencies for active substances with DLP 2025 based on a risk-based approach (M.Lopez Fauqued, GPAG) (PDF/256.73 KB)
First published: 30/11/2022 -
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Presentation - International transfer of personal (health) data in ICSRs originating from EudraVigilance (S.Brosch, EMA) (PDF/133.89 KB)
First published: 30/11/2022 -
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Presentation - Good Pharmacovigilance Practices (EU-GVP) - Update (P.Bahri, EMA) (PDF/745.24 KB)
First published: 30/11/2022