Union Pharmacovigilance Database: webinar on adverse event collection and recording

• Date:
  Wednesday, 10 November 2021 , 14:00 - 17:00 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. The European Medicines Agency will therefore launch an enhanced and upgraded EudraVigilance Veterinary (EVVet3) system to process and manage veterinary pharmacovigilance messages.

EVVet3 will provide the following capabilities:

• Data submission, which includes the sending of adverse event report (AER) messages either via a gateway or a user interface. It also includes validation, conversion, routing, loading and acknowledgement of messages, as well as supporting functionalities to search, view and download AER data.
• Data quality management, which includes the processes of message recoding, duplicate management and transformation of data for the analytical tools.
• Data analysis, which involves the tools for analysing AER data for signal detection, signal prioritisation, signal validation, signal evaluation and recommendation for action.
• Signal management and pharmacovigilance (PhV) inspection outcomes, which provides for the processing of signal management activities carried out by the marketing authorisation holder and the storing of the results of pharmacovigilance inspections.
• Data publishing, which involves making AER data and other information related to pharmacovigilance activities available to the public.
• Integration points with other systems, such as user registration and management and management of organisation data, controlled terminologies, and product data.

This webinar is part of a series of training events on the new EVVet3 system and it will provide general principles on:

• the new requirements on collection and recording of suspected adverse events for veterinary medicinal products;
• demonstration of the basic functionalities of EVV system for recording, searching and downloading suspected adverse event reports.

Please note this meeting will be recorded for training purposes and the recording will be published on EMA's YouTube channel. By registering to this event, you are providing consent to EMA to process your personal data in in accordance with Regulation (EU) 2018/1725.

Documents

Agenda - Union Pharmacovigilance Database: webinar on adverse event collection and recording

Draft Reference Number: EMA/597574/2021

Presentation - VGVP module on collection and recording of suspected adverse events for veterinary medicinal products and EVV system functionalities (L. Descalzo and G. Spyrou)

List of Q&As received during the webinar training on 10 November 2021: VGVP module on collection and recording of suspected adverse events for veterinary medicinal products & EVV system functionalities

Reference Number: EMA/679405/2021

Video recording