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

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Date: Dé hAoine, 3 Feabhra 2017, All day
Áit: 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)

Foilsíodh den chéad uair é: 16/05/2017 An nuashonrú is déanaí: 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)

Foilsíodh den chéad uair é: 02/02/2017 An nuashonrú is déanaí: 02/02/2017

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

English (EN) (536.95 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

Presentation - 2017 PRAC work plan (June Raine)

English (EN) (251.87 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

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

English (EN) (130.15 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

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

English (EN) (1.53 MB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

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

English (EN) (164.54 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

Presentation - PSUR roadmap (Irene Rager)

English (EN) (230.79 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

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

English (EN) (347.42 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017

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

English (EN) (343.76 KB - PDF)

Foilsíodh den chéad uair é: 30/03/2017 An nuashonrú is déanaí: 30/03/2017