Twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union

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Date

Fredag, 24 november 2017, Hele dagen

Placering

European Medicines Agency, Amsterdam, the Netherlands

The twelfth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system.

Documents

Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union

Reference Number: EMA/790351/2017

English (EN) (143.92 KB - PDF)

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Agenda - Twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union

Reference Number: EMA/666321/2017

English (EN) (80.73 KB - PDF)

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Presentation - CMDh project on ideas for WS of assessment of RMPs and informal WS procedure for follow up requests after a PSUSA for NAPs (K. van der Stoep)

English (EN) (120.07 KB - PDF)

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Presentation - EudraVigilance project: launch of the new system (F. Domergue)

English (EN) (647.14 KB - PDF)

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Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (P. Bahri)

English (EN) (64.36 KB - PDF)

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Presentation - GVP paediatric population and “direction of travel” (R. De Lisa)

English (EN) (65.93 KB - PDF)

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Presentation - Encouraging joint PASS submissions (I. Rager)

English (EN) (104.79 KB - PDF)

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Presentation - United Kingdom's withdrawal from the European Union preparedness activities - Q&A session on PhV Brexit related topic (M. Pinheiro)

English (EN) (226 KB - PDF)

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