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

• Date:
  Friday, 2 June 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The eleventh platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system includes discussions on GVPs and signal management process.

Documents

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

AdoptedReference Number: EMA/286244/2017

Minutes - Highlights from the 11th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation

Reference Number: EMA/369620/2017

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

Presentation - GVP V and RMP template Rev 2 – update on implementation (Nàºria Semis-Costa and Emil Cochino)

Presentation - GVP Module VI – ADR, pharmacovigilance guideline for paediatric medicines (Roberto De Lisa and Priya Bahri)

Presentation - MAHs access to EudraVigilance (Rodrigo Postigo)

Presentation - Update on EudraVigilance Auditable Requirements project (Georgy Genov)

Presentation - Update on PRAC work plan and impact strategy (June M. Raine)