15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Date:
  Freitag, 30 Oktober 2020, Ganztägig
• Ort:
  European Medicines Agency, Amsterdam, the Netherlands

This platform meeting with industry stakeholder associations covered the following topics:

• monitoring of COVID-19 products (vaccines and therapeutics);
• good pharmacovigilance practices (GVPs) update;
• EudraVigilance (EV) operational plan (milestones 2020-2022);
• preparations for the end of transition period for UK’s withdrawal from the EU.
• paper on the reference safety information (RSI) by Medicines for Europe 

Documents

Agenda - 15th industry stakeholder platform - Operation of European Union (EU) pharmacovigilance

Reference Number: EMA/342512/2020

Meeting highlights - 15th industry stakeholder platform - Operation of European Union (EU) pharmacovigilance

Reference Number: EMA/582239/2020

Presentation - Update of EudraVigilance operational plan (milestones 2020-2022) (Rodrigo Postigo)

Presentation - Good pharmacovigilance practices (GVP) - GVP PIII update after public consultation (Corinne de Vries)

Presentation - Good pharmacovigilance practices (GVP) - GVPs updates including GVP XVI and PASS addendum (Priya Bahri)

Presentation - Monitoring of COVID-19 products (vaccines and therapeutics) (Georgy Genov)

Presentation - Preparations for the end of transition period for UK’s withdrawal from the EU (Marie-Helene Pinheiro)