Union Pharmacovigilance Database: follow up webinar on signal detection, evaluation and yearly reporting

• Date:
  Wednesday, 19 January 2022, All day
• 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 second session dedicated to the new signal management requirements will come back to areas and common questions raised during the first webinar on 23 and 24 November 2021. In addition, this session will focus on how to submit signals and annual statements, allowing for sufficient time to address any questions related to signal management of veterinary medicinal products in the EU.

A video recording of the event will be made available after the event.

Documents

Agenda - Union Pharmacovigilance Database: follow up webinar on signal detection, evaluation and yearly reporting

Reference Number: EMA/6754/2022

Presentation - UPD: Follow up webinar on signal detection, evaluation and yearly reporting - Signal management highlights (D.Zondag, EMA)

Presentation - EVV DWH Dashboard and Reports (L.Descalzo, EMA)

Presentation - Pilot Signal Management Expert Group (P-SMEG)