Eighth industry stakeholder platform: operation of the European Union (EU) pharmacovigilance legislation

• Date:
  fredag, 1 juli 2016, Hela dagen
• Plats:
  European Medicines Agency, Amsterdam, the Netherlands

The eighth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system discussed risk management plan guidance and templates, the Eudravigilance system and medical literature monitoring. The agenda of the meeting and the Agency's presentations are published on this website.

Documents

Highlights from the eighth European Medicines Agency Industry Platform meeting on the operation of European Union pharmacovigilance legislation - 1 July 2016

Reference Number: EMA/459864/2016

Agenda - Eighth industry stakeholder platform: operation of EU pharmacovigilance legislation

Reference Number: EMA/375852/2016

Presentation - Pharmacovigilance system master file: discussion of the need to revise GVP guidance (Sophia Mylona)

Presentation - Risk management plan guidance and templates: feedback from the public consultation (Emil Cochino)

Presentation - European Medicines Agency questions and answers on risk management plan (RMP) updates for centrally authorised medicinal products (Iordanis Gravanis)

Presentation - EudraVigilance change management planning: latest updates, new webpage and training support (Francois Domergue)

Presentation - Highlights of the European Medicines Agency medical literature monitoring stakeholder survey (Thomas Paternoster-Howe)

Presentation - Update on pharmacovigilance guidances (Peter Arlett)

Presentation - Update on IDMP/SPOR stakeholder engagement approach (Agnieszka Laka)