--- title: Requirements of an EU PV system – Signal Management description: Signal management is complex and requires a customized approach to each product. Read this article to optimize your signal management strategies with our assistance! image: https://blog.pqegroup.com/hubfs/Requirements%20of%20an%20EU%20PV%20system_Site%20PQE%20(1).jpg --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![](https://blog.pqegroup.com/hubfs/blank-user.png) Alex Xuereb QA/PV specialist @Quintian Pharma # **Requirements of an EU PV system – Signal Management** [GxP Compliance](https://blog.pqegroup.com/tag/gxp-compliance) ## Challenges Faced by Marketing Authorization Holders in Signal Management for Pharmacovigilance Systems A critical part of any pharmacovigilance (PV) system is the process of signal management. As per article 19 of the Commission Implementing Regulation (EU) No 520/2012, Marketing Authorization Holders (MAHs) are legally required to identify new or changing adverse events related to their medicinal product or Active Pharmaceutical Ingredient (API).  The challenge comes when deciding on how to identify, validate and act on these new adverse events in an appropriately scientific manner.   ## Current MAHs Issues Many MAHs are faced with the following issues:  - Huge quantities of safety data, often in the form of spontaneous Adverse Drug Reports (ADRs) or as Individual Case Safety Reports (ICSRs), are collected or available that can vary greatly in quality. - The data being collected is decentralized and does not have the luxury of being collected from a clinical trial where variables can be tightly monitored and compared to a control. - EU guidelines on signal management leave room for interpretation and innovation, as they often do. This can be difficult for untrained personnel who are looking to transpose these guidelines into their own functioning PV and signal management systems. [Read the full article on QuintianPharma.com](https://quintianpharma.com/2024/04/10/requirements-of-an-eu-pv-system-signal-management/) ![Requirements of an EU PV system_Site PQE (1)](https://blog.pqegroup.com/hubfs/Requirements%20of%20an%20EU%20PV%20system_Site%20PQE%20(1).jpg) ## Are you ready for change? PQE Group can support your business in reaching the compliance for your products as well as in implementing new procedures, tools and software. To get more information or support, [get in touch with us](https://www2.pqegroup.com/contact-us/) or check our [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) dedicate page to find the most suitable solution for your company. [Connect with us](https://www2.pqegroup.com/contact-us/) #### More on this topic [GxP Compliance ![The FDA Guide to AI in Drug Development](https://blog.pqegroup.com/hubfs/FDA%20guidance%20on%20AI_Blog.webp)](https://blog.pqegroup.com/gxp-compliance/the-fda-guide-to-ai-in-drug-development) 30 Jun 2026 ## [The FDA Guide to AI in Drug Development Read more about how the FDA is redefining AI in drug development from regulatory guidance to compliance expectations.](https://blog.pqegroup.com/gxp-compliance/the-fda-guide-to-ai-in-drug-development) [GxP Compliance ![Why Your Path to Sustainability Should Start With ESG](https://blog.pqegroup.com/hubfs/Path%20to%20Sustainability%20ESG_Blog-2.webp)](https://blog.pqegroup.com/gxp-compliance/why-your-path-to-sustainability-should-start-with-environmental-social-and-governance-esg) 09 Jun 2026 ## [Why Your Path to Sustainability Should Start With ESG ESG is reshaping the pharmaceutical industry, discover how new regulations are driving transparency, compliance, and sustainable growth.](https://blog.pqegroup.com/gxp-compliance/why-your-path-to-sustainability-should-start-with-environmental-social-and-governance-esg) [GxP Compliance ![CSA Validation Strategies in SAP S/4HANA®](https://blog.pqegroup.com/hubfs/CSA%20SAP%204%20HANA_Blog-2.webp)](https://blog.pqegroup.com/gxp-compliance/csa-validation-strategies-in-sap-s/4hana) 27 May 2026 ## [CSA Validation Strategies in SAP S/4HANA® Discover CSA in SAP S/4HANA validation and its digital approach focused on risk and efficiency.](https://blog.pqegroup.com/gxp-compliance/csa-validation-strategies-in-sap-s/4hana) ![new PQE logo white tagline](https://blog.pqegroup.com/hubfs/new%20PQE%20logo%20white%20tagline.png) ISO 9001 Certified compliance services provider since 1998.   ![Logo ISO 9001](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20ISO%209001.png?width=125&name=Logo%20ISO%209001.png)   - Discover PQE - [Work with PQE](https://www2.pqegroup.com/careers/) - [Locations](https://www2.pqegroup.com/contact-us/#locations) - [About](https://www2.pqegroup.com/about/) - [Blog](https://blog.pqegroup.com/) - Useful Links - [Privacy Notice](https://www2.pqegroup.com/privacy-notice/) - [Cookie Policy](https://www2.pqegroup.com/cookie-policy/) - [Model of Organization](https://www2.pqegroup.com/model-of-organization/) - [Ethical Code](https://www2.pqegroup.com/ethical-code/) English - [English](https://blog.pqegroup.com/gxp-compliance/requirements-eu-pv-system-signal-management) - [Français](https://blog.pqegroup.com/fr/gxp-compliance/exigences-systeme-pv-eu-signal-management) - [日本語](https://blog.pqegroup.com/ja/gxp-compliance/requirements-eu-pv-system-signal-management) CHANGE LANGUAGE Copyright **2024** | Proudly powered by **PQE Group Creative Team** [LinkedIn](https://www.linkedin.com/company/pqe-group) [![twitter](https://blog.pqegroup.com/hubfs/twitter-w.png) Twitter](https://twitter.com/PQEGroup) [Facebook](https://www.facebook.com/PQEGroup/) [Instagram](https://www.instagram.com/lifeatpqe) [YouTube](https://www.youtube.com/c/PQEGroup) [Xing](https://www.xing.com/pages/pqegroup)