An agency of the European Union
GVP V and RMP Template Rev 2 – Update
on implementation
11th industry stakeholder platform, 02 June 2017
Núria Semis-Costa and Emil Cochino
Scientific and Regulat
08.06.2017
Datei
PD
An agency of the European Union
MAHs access to EudraVigilance
Rodrigo Postigo - Signal & Incident Management - Pharmacovigilance & Epidemiology
Stakeholders meeting – 02 June 2017
Content
Bac
08.06.2017
Datei
PD
An agency of the European Union
Update on EudraVigilance Auditable Requirements
project
Georgy Genov
Acting Head of Pharmacovigilance & Epidemiology Department
11th industry stakeholder platform –
08.06.2017
Datei
PD
patients • quality • value • sustainability • partnership
11th industry Stakeholder
Platform meeting 02 Jun 2017
Signal management process
Nicole Lang, Sr. Director,TEVA
Medicines for Europe
Sign
08.06.2017
Datei
PD
patients • quality • value • sustainability • partnership
Risk Management Plan –
assessment process proposal
11th industry stakeholder platform – operation of EU
pharmacovigilance
2 June 2017
Pre
08.06.2017
Datei
PD
Risk Management Plan –
assessment process proposal
Endorsed by:
Pharmacovigilance Stakeholder Platform meeting
2nd June 2017, EMA, London
Presenter: Michael Forstner, Samsung Bioepis
From the
08.06.2017
Datei
PD
Industry Stakeholder meeting
EMA
SCOPE update
2 June 2017
Dr June Raine
MHRA, UK
SCOPE outputs
Pilot Training
Survey Reports
Training WPs 4, 5, 7 and 8
ADR Awareness Campaign
Stakeholder m
08.06.2017
Datei
PD
Signal Management Process
Presentation by Industry
Endorsed by:
Pharmacovigilance Stakeholder Platform meeting
2nd June 2017, EMA, London
Part 1:
Feedback on GVP IX (R1) Implementation based o
08.06.2017
Datei
PD
An agency of the European Union
Update Good pharmacovigilance practices for the EU
GVPs status and updates on GVP
(GVP Module VI – ADR, pharmacovigilance guideline for
paediatric medicines)
Rober
08.06.2017
Datei
PD
Nachfolgend werden die wichtigesten Themen und Ergebnisse zusammen gefasst. Eudravigilance auditable requirements – Georgy Genov von der EMA berichtete hierzu. Die volle Funktionfähigkeit von Eudravig
08.06.2017
Meldung
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