15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
Date:
30/10/2020
This platform meeting with industry stakeholder associations covered the following topics:
- monitoring of COVID-19 products (vaccines and therapeutics);
- good pharmacovigilance practices (GVPs) update;
- EudraVigilance (EV) operational plan (milestones 2020-2022);
- preparations for the end of transition period for UK’s withdrawal from the EU.
- paper on the reference safety information (RSI) by Medicines for Europe
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Agenda - 15th industry stakeholder platform - Operation of European Union (EU) pharmacovigilance (PDF/163.05 KB)
First published: 17/11/2020
EMA/342512/2020 -
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Meeting highlights - 15th industry stakeholder platform - Operation of European Union (EU) pharmacovigilance (PDF/142.4 KB)
First published: 18/11/2020
EMA/582239/2020 -
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Presentation - Update of EudraVigilance operational plan (milestones 2020-2022) (Rodrigo Postigo) (PDF/1.38 MB)
First published: 17/11/2020 -
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Presentation - Good pharmacovigilance practices (GVP) - GVP PIII update after public consultation (Corinne de Vries) (PDF/437.6 KB)
First published: 17/11/2020 -
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Presentation - Good pharmacovigilance practices (GVP) - GVPs updates including GVP XVI and PASS addendum (Priya Bahri) (PDF/393.25 KB)
First published: 17/11/2020 -
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Presentation - Monitoring of COVID-19 products (vaccines and therapeutics) (Georgy Genov) (PDF/827.36 KB)
First published: 17/11/2020 -
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Presentation - Preparations for the end of transition period for UK’s withdrawal from the EU (Marie-Helene Pinheiro) (PDF/922.64 KB)
First published: 17/11/2020