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

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Date: Piektdiena, 3 Februāris 2017, Visu dienu
Vieta: European Medicines Agency, Amsterdam, the Netherlands

The tenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will discuss good pharmacovigilance practices, periodic safety update reports and registries.

Documents

Minutes - Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union

Reference Number: EMA/80558/20177

English (EN) (113.84 KB - PDF)

Pirmo reizi publicēts: 16/05/2017 Pēdējo reizi atjaunināts: 16/05/2017

Agenda - Tenth industry stakeholder platform on the operation of EU pharmacovigilance

Reference Number: EMA/42931/2016

English (EN) (176.32 KB - PDF)

Pirmo reizi publicēts: 02/02/2017 Pēdējo reizi atjaunināts: 02/02/2017

Presentation - Progress update: MLM and EV auditable requirements project (Georgy Genov)

English (EN) (536.95 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

Presentation - 2017 PRAC work plan (June Raine)

English (EN) (251.87 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

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

English (EN) (130.15 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

Presentation - EU PASS/PAES requirements for disclosure (Thomas Goedecke)

English (EN) (1.53 MB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

Presentation - Consultation on the explanatory note to GVP Module VII (CBG MEB)

English (EN) (164.54 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

Presentation - PSUR roadmap (Irene Rager)

English (EN) (230.79 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

Presentation - MAH compliance with PRAC signal recommendations for PI update of CAPs (Aniello Santoro)

English (EN) (347.42 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017

Presentation - Registries: Recommendations from the registries workshop (Xavier Kurz)

English (EN) (343.76 KB - PDF)

Pirmo reizi publicēts: 30/03/2017 Pēdējo reizi atjaunināts: 30/03/2017