Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation

• Date:
  Monday, 12 January 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This meeting focused primarily on experience with risk-management plans (RMP) and post-authorisation safety studies (PASS), with regulators presenting an update on recent developments and stakeholders providing valuable practical feedback on the available guidance and templates. An update on the development of a scientific and regulatory guideline for post-authorisation efficacy studies (PAES) was also provided. Registration by invitation only. Registration closed.

Documents

Agenda - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation

Adopted Reference Number: EMA/654663/2014

Highlights - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation

Reference Number: EMA/38167/2015

Participants list - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation

Reference Number: EMA/91293/2015

Presentation - Guidance on post-authorisation efficacy studies (Jane Moseley)

Presentation - Post-authorisation safety studies (PASS) (Irene Rager)

Presentation - Periodic safety update report (PSUR) repository (Irene Rager)

Presentation - Questions and answers on off-label use ( Sabine Brosch and Anja Haren)

Presentation - Risk-management planning (Luis Prieto)

Presentation - Strategy and pilot phase for patient registries (Xavier Kurz)

Presentation - The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP): Facilitating the conduct of post-authorisation study (PAS) (Henry Fitt)

Presentation - Update on development of pharmacovigilance information systems (Peter Arlett)