Webinar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files: Introduction and principles
Table of contents
Date:
08/12/2021
Location:
Online, 10:00-13:00 Amsterdam time (CET)
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.
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Agenda - Webinar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files: Introduction and principles (PDF/99.74 KB)
Draft
First published: 17/11/2021
Last updated: 22/11/2021
EMA/618317/2021 -
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Presentation - VGVP module on controls and pharmacovigilance inspections: Introduction and principles (Calogero Cannavo) (PDF/1.84 MB)
First published: 10/12/2021 -
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Presentation - VGVP module on pharmacovigilance systems, their quality management systems and pharmacovigilance system master files (Sophia Mylona) (PDF/964.58 KB)
First published: 10/12/2021