11th stakeholder forum on the pharmacovigilance legislation

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Date: Ceturtdiena, 21 Septembris 2017, Visu dienu
Vieta: 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)

Pirmo reizi publicēts: 25/08/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (1.66 MB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 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)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (2.91 MB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (4.14 MB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (393.06 KB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (484.69 KB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (576.77 KB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

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

English (EN) (677.74 KB - PDF)

Pirmo reizi publicēts: 28/09/2017 Pēdējo reizi atjaunināts: 28/09/2017

Multimedia

Session 1

Session 2

Session 3