Union Pharmacovigilance Database: webinar on signal detection and analysis
EventVeterinaryRegulatory and procedural guidancePharmacovigilance
Date
- Tuesday, 23 November 2021, 10:00 (CET) - 13:00 (CET)
Location
- OnlineEuropean 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 will focus on some practical aspects and the implementation of the module on signal management of the guideline on veterinary good pharmacovigilance practices. Topics to be covered in this webinar include:
- Overall approach to signal management for marketing authorisation holders (MAHs);
- Accessing and running queries in the Union Pharmacovigilance Database;
- Practical aspects of signal detection in the Union Pharmacovigilance Database;
- Frequency of monitoring;
- Medically important terms for signal prioritisation;
- Demo session showing the queries available for MAHs and how to perform signal management and take advantage of the full dataset;
- Q&A session (practical questions).
For more information, please see:
Please note this meeting will be recorded for training purposes and the recording will be published. By registering to this event, you are providing consent to EMA to process your personal data in in accordance with Regulation (EU) 2018/1725.