February 23, 2026
The signal management process, critical in Pharmacovigilance, consists of a set of activities carried out to determine whether new risks are associated with an active substance or medicinal product, or whether known risks have changed. Marketing Authorisation Holders (MAHs) of medicinal products approved in the European Union are legally required to continuously monitor product safety and maintain a signal management process. This training aims to present a comprehensive and integrated approach to the legal requirements applicable to signal detection within the European Union, its implementation, and recent/forthcoming changes to the process requirements.
• Present the legal foundations underpinning signal management within the European Union;
• Analyse the legislative changes introduced in 2025/2026, including the updated version of the Guideline on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management, expected to be released in the second quarter of 2026, and discuss the impact of these changes on the organisational structure and practices of MAHs.
• Describe the various stages of the signal management process and discuss possible methodologies;
• Highlight the importance of integrating EudraVigilance Data Analysis System (EVDAS) analysis into the signal detection process;
• Describe the importance of MAHs to monitor signals assessed by authorities and cooperate in safety evaluations.
1. Definitions and legal framework;
2. Changes to European legislation occurring in 2025/2026 and their impact on the signal management process.
3. Stages of the signal management process;
4. Methodologies applicable to signal management and analysis of their suitability to the MAH’s organisation;
5. EVDAS as an essential tool in signal management;
6. The role of competent authorities in signal management.
Registration may be completed online at https://www.owlpharma.pt/knowledge. Alternatively, you may register by completing the attached form and sending it to knowledge@owlpharma.pt. You will receive an email confirming availability and providing payment details. Registration will only be considered complete upon confirmation of payment.
200 € + VAT
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