--- title: "From Pilot to Practice: Signal Management Under Regulation (EU) 2025/1466" description: "This webinar goes beyond the text of Regulation (EU) 2025/1466 and into its practical implications, helping MAHs decide how to integrate EudraVigilance data into signal management and justify that choice in an inspection." url: https://qbdgroup.com/en/webinars/signal-management-regulation-eu-2025-1466 type: "Webinar" language: en published: 2026-10-07 author: "QbD Group" category: "Pharmacovigilance" publisher: "QbD Group" citation: "QbD Group, \"From Pilot to Practice: Signal Management Under Regulation (EU) 2025/1466\", https://qbdgroup.com/en/webinars/signal-management-regulation-eu-2025-1466" --- # From Pilot to Practice: Signal Management Under Regulation (EU) 2025/1466 > This webinar goes beyond the text of Regulation (EU) 2025/1466 and into its practical implications, helping MAHs decide how to integrate EudraVigilance data into signal management and justify that choice in an inspection. _A practical look at what the Regulation asks of MAHs, the decisions behind it, and how to implement and defend your approach_ 🕐 3 PM CET ## Introduction Regulation (EU) 2025/1466 amends Implementing Regulation (EU) No 520/2012, which sets out how pharmacovigilance activities are carried out in the EU. Its signal management provisions changed the framework for Marketing Authorization Holders (MAHs), including the end of the EudraVigilance signal detection pilot and the removal of the requirement to submit validated signals as standalone signal notifications. MAHs are now expected to describe in their pharmacovigilance and signal management procedures how EudraVigilance data will be monitored and how it will be used alongside other available sources. The frequency and approach should be proportionate to the product's risk profile, and both documented and justified. The legal requirements already apply, while EMA has indicated that GVP Module IX will be updated to reflect the revised framework. In the meantime, companies need to work with the amended Implementing Regulation, the current GVP framework and EMA's dedicated Q&A. ## About the webinar Most available content on Regulation (EU) 2025/1466 explains what the text says. This session starts there, with a clear review of **what has changed and where things stand today**, then moves to the practical questions companies are now facing: - Where should EudraVigilance data sit within your signal management process? - Should it be a primary detection source, an additional source, or used mainly during validation and evaluation? - How often should EudraVigilance data be reviewed, and how can a risk-based frequency be justified? - What evidence should be available to demonstrate inspection readiness? Rather than presenting one model as universally preferable, the webinar compares the practical options available to MAHs and the trade-offs of each. The discussion focuses on the criteria that should drive the decision: portfolio size and complexity, product risk profile, internal resources, prior experience with EudraVigilance, outsourcing capacity and governance. Case studies will show how different organizations have approached these decisions in practice, across **in-house, hybrid and outsourced operating models**, drawing on QbD Group's [Pharmacovigilance](https://qbdgroup.com/en/services/pharmacovigilance) expertise. ## What You'll Learn - What Regulation (EU) 2025/1466 changes in signal management, which articles are affected and where the process stands today - How the current guidance landscape fits together: Regulation 2025/1466, the current GVP framework, EMA Q&A and the upcoming revision of GVP Module IX - Which options MAHs have to integrate EudraVigilance data into their signal management processes - The advantages, limitations and resource implications of each option - Which criteria to apply when choosing an approach, from portfolio size and risk profile to internal capacity and outsourcing - How to document and justify your decision so it holds up in an audit or inspection ## Speakers ### Almudena del Castillo **Global Head of Vigilance · QbD Group** Dr. Almudena del Castillo is a Medical Doctor and Specialist in Family and Community Medicine with extensive expertise in pharmacovigilance, regulatory affairs and drug safety. She previously worked at major pharmaceutical companies including Pfizer, and served as VP of Sales and Business Development at Pharmalex and PLG. She currently leads the Drug Safety and Vigilance division at QbD Group. ### Aleksandra Zmysłowska-Baryła **Senior Consultant Drug Safety | Team Lead · QbD Group** ![Aleksandra Zmysłowska-Baryła](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/avatars/aleksandra-zmyslowska-baryla.png) Aleksandra is a pharmacist with postgraduate expertise in Pharma Business. She has been responsible for developing, implementing and continuously improving PV systems, including processes and procedures, oversight models, and audit- and inspection-ready frameworks. As Team Lead and Senior Drug Safety Consultant at QbD Group, she leads a team handling ICSR management, signal management and xEVMPD activities, while coordinating PV projects and supporting cross-functional work. ### Irene Santos **Consultant Drug Safety · QbD Group** ![Irene Santos](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/avatars/irene-santos.png) Irene is a pharmacist with a master's degree in clinical trials monitoring. She has built her career in drug safety with a particular focus on ICSR management and signal detection across several consultancy organizations. Before joining QbD Group, she was Senior Drug Safety Officer at Asphalion. As Drug Safety Consultant at QbD Group, she draws on that experience to support clients. ## Who Should Attend - Heads, Directors and Managers of Pharmacovigilance / Drug Safety - Pharmacovigilance professionals managing signal detection, evaluation and reporting - QPPVs and Deputy QPPVs - Regulatory Affairs and Quality professionals involved in PSUR/RMP effectiveness and inspection readiness - Procurement and outsourcing managers evaluating pharmacovigilance operating models and external support --- Source: https://qbdgroup.com/en/webinars/signal-management-regulation-eu-2025-1466 — © QbD Group. Quote freely with attribution and a link back.