EMA publishes QPPV Update

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

In April 2016 the European Medicines Agency (EMA) published the first issue of  the quarterly issued  "QPPV Update - What´s new in Pharmacovigilance". The "QPPV Update" replaces the "Pharmacovigilance Programme Update" which focused on information systems and services.

The new newsletter contains general information regarding pharmacovigilance and provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU pharmacovigilance.

The first issue of the "QPPV Update" covers the following topics:

• Pharmacovigilance in the product lifecycle,
• Pharmacovigilance processes,
• Pharmacovigilance guidance,
• Pharmacovigilance IT systems,
• Pharmacovigilance dialogue.

Qualified Persons for Pharmacovigilance (QPPVs) who are registered in the XEVMPD database according to Article 57 of Regulation (EG) No 726/2004 receive this document directly via EudraLink. You can find the Newsletter on the website of the EMA.