Webinar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files: Introduction and principles

• Date:
  Wednesday, 08 December 2021 , 10:00 - 13:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) calls for the establishment of a Union Pharmacovigilance Database by 28 January 2022.

This webinar is part of a series of training events and it will provide general principles on:

• the planning, conduct, reporting, follow-up and operation of pharmacovigilance inspections in the EU for monitoring of Marketing Authorisation Holder compliance with pharmacovigilance obligations.
• the basic requirements on the pharmacovigilance system, its integral quality management system and the pharmacovigilance system master file (PSMF) that marketing authorisation holders for veterinary medicinal products authorised in the European Union (EU) should establish and maintain.

A video recording will be available after the event.

Documents

Agenda - Webinar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files: Introduction and principles

Draft Reference Number: EMA/618317/2021

Presentation - VGVP module on controls and pharmacovigilance inspections: Introduction and principles (Calogero Cannavo)

Presentation - VGVP module on pharmacovigilance systems, their quality management systems and pharmacovigilance system master files (Sophia Mylona)

Video recording