11th stakeholder forum on the pharmacovigilance legislation

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Date: Thursday, 21 September 2017, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Documents

Agenda – Eleventh stakeholder forum on the pharmacovigilance legislation

Adopted Reference Number: EMA/303132/2017

English (EN) (87.45 KB - PDF)

First published: 25/08/2017 Last updated: 28/09/2017

Presentation - Future opportunities for pharmacovigilance (à. Spooner, HPRA and PRAC)

English (EN) (1.66 MB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - How patients and healthcare professionals can be involved in public hearings (J. Garcia Burgos, EMA)

English (EN) (1.9 MB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - Pharmacovigilance Risk Assessment Committee - Five years of operation (J. Raine, PRAC)

English (EN) (2.91 MB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - Strengthening collaborations for operating pharmacovigilance in Europe Joint Action (L. Loughlin, MHRA)

English (EN) (4.14 MB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - EudraVigilance – new functionalities and EudraVigilance access policy (patient access) (S. Brosch, EMA)

English (EN) (393.06 KB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - Patient Registries Initiative Lessons learned from the recent workshops (X. Kurz, EMA)

English (EN) (484.69 KB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - Signal management process (G. Genov, EMA)

English (EN) (576.77 KB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Presentation - Learnings & next steps for EMSP as initiator and driver (C.Thalheim, J.Hlavacova)

English (EN) (677.74 KB - PDF)

First published: 28/09/2017 Last updated: 28/09/2017

Multimedia

Session 1

Session 2

Session 3