{"id":5109,"date":"2026-01-28T10:51:51","date_gmt":"2026-01-28T09:51:51","guid":{"rendered":"https:\/\/www.evalii.de\/?p=5109"},"modified":"2026-01-28T10:51:55","modified_gmt":"2026-01-28T09:51:55","slug":"eu-verordnung-2025-1466-pharmakovigilanz-evalii","status":"publish","type":"post","link":"https:\/\/www.evalii.de\/en\/2026\/01\/28\/eu-verordnung-2025-1466-pharmakovigilanz-evalii\/","title":{"rendered":"Implementing regulatory requirements with evalii\u00ae: EU Regulation 2025\/1466, pharmacovigilance and auditable processes"},"content":{"rendered":"
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With the\u00a0EU Regulation 2025\/1466<\/b>\u00a0Key requirements for the\u00a0Pharmacovigilance (PV)<\/b>\u00a0Noticeably, the focus is shifting away from pure formalism towards\u00a0Traceability, process quality and transparent documentation<\/b>. For pharmaceutical companies, this means specifically: PV processes must not only function, but\u00a0proven<\/b>,\u00a0versioned<\/b>\u00a0and\u00a0auditable<\/b>\u00a0be, and that is along the entire process chain from detection to action.\u00a0<\/span><\/p>\n

This increases expectations for the organization, IT systems, and governance alike. In particular, the following are required:\u00a0<\/span><\/p>\n

    \n
  • Complete documentation of PV-relevant content and decisions\u00a0<\/span><\/li>\n<\/ul>\n
      \n
    • Risk-based assessment of deviations and process risks\u00a0<\/span><\/li>\n<\/ul>\n
        \n
      • Rapid response to potentially critical messages\u00a0<\/span><\/li>\n<\/ul>\n
          \n
        • international data standards and consistent chains of evidence\u00a0<\/span><\/li>\n<\/ul>\n
            \n
          • Audit and inspection capability for internal and regulatory audits\u00a0<\/span><\/li>\n<\/ul>\n

            evalii\u00ae<\/b>\u00a0It provides the technological and procedural foundation for this. The platform supports companies not only in meeting regulatory requirements, but also in...\u00a0to actively control<\/b>.\u00a0<\/span><\/p>\n

            \u00a0evalii\u00ae is a\u00a0structured system for monitoring, evaluation and\u00a0<\/b>Documentation of potentially pharmacovigilance-relevant content, especially from digital channels. This is precisely where a practical problem often lies: While companies can often monitor social media, contact forms, or platform comments, the regulatory-required documentation is often manual, fragmented, and not consistently audit-proof.\u00a0<\/span><\/p>\n

            evalii\u00ae provides a solution here by handling all process steps\u00a0standardized and<\/b>\u00a0understandable<\/b>\u00a0be depicted.\u00a0<\/span><\/p>\n

            The platform helps answer key audit questions such as:\u00a0<\/span><\/p>\n

              \n
            • Which message was detected and when?\u00a0<\/span><\/li>\n<\/ul>\n
                \n
              • How was it evaluated, classified, and prioritized?\u00a0<\/span><\/li>\n<\/ul>\n
                  \n
                • To whom was it forwarded and when?\u00a0<\/span><\/li>\n<\/ul>\n
                    \n
                  • Who was involved and what measures were taken?\u00a0<\/span><\/li>\n<\/ul>\n

                    This creates a\u00a0transparent, audit-proof workflow<\/b>, which can be adapted to existing role models and SOPs.\u00a0<\/span><\/p>\n

                    \u00a0The new EU regulation reinforces the requirement that PV processes not only be "lived" but also\u00a0formally verifiable<\/b>\u00a0must be. In practice, this means that companies need documented proof that...,\u00a0<\/span><\/p>\n

                      \n
                    • that PV-relevant content\u00a0identified<\/b>\u00a0become,\u00a0<\/span><\/li>\n<\/ul>\n
                        \n
                      • like her\u00a0rated<\/b>\u00a0become,\u00a0<\/span><\/li>\n<\/ul>\n
                          \n
                        • how decisions are made,\u00a0<\/span><\/li>\n<\/ul>\n
                            \n
                          • and which\u00a0Measures<\/b>\u00a0were hit.\u00a0<\/span><\/li>\n<\/ul>\n

                            With evalii\u00ae, this documentation no longer becomes a manual effort.\u00a0\u00a0<\/span><\/p>\n

                            This particularly supports:\u00a0<\/span><\/p>\n

                            Compliance with new PSMF (Pharmacovigilance System Master File) requirements<\/b>\u00a0<\/span><\/p>\n

                            The demands placed on the PV system and its documentation are increasing. evalii\u00ae enables the consistent mapping of process logic, responsibilities, and decision-making paths \u2013 an essential foundation for auditable PV documentation.\u00a0<\/span><\/p>\n

                            Risk-based assessment of process deviations<\/b>\u00a0<\/span><\/p>\n

                            Instead of blanket formalism, risk-based analysis takes center stage: Which deviations are critical? Which are tolerable? What measures are required? evalii\u00ae provides structured data foundations for this.\u00a0<\/span><\/p>\n

                            Audits require a complete and transparent justification of decisions and responsibilities. evalii\u00ae provides a comprehensive history for this purpose: Who assessed what, when, and why? This reduces audit effort and provides security when dealing with regulatory inquiries.\u00a0<\/span><\/p>\n

                            Digital channels are now a key risk factor and, at the same time, a crucial information space. Continuous monitoring is therefore not only an organizational obligation but increasingly a governance requirement: companies must ensure that relevant content is identified and assessed before it gives rise to regulatory or liability risks.\u00a0<\/span><\/p>\n

                            evalii\u00ae offers not only safety, but a genuine\u00a0Early warning function<\/b>:\u00a0<\/span><\/p>\n

                              \n
                            • Potentially critical content is identified.\u00a0<\/span><\/li>\n<\/ul>\n
                                \n
                              • prioritized and classified\u00a0<\/span><\/li>\n<\/ul>\n
                                  \n
                                • assigned to the relevant authorities\u00a0<\/span><\/li>\n<\/ul>\n
                                    \n
                                  • and documented along the process chain\u00a0<\/span><\/li>\n<\/ul>\n

                                    This creates responsiveness \u2013 and at the same time the required verifiability.\u00a0<\/span><\/p>\n

                                    \u00a0Conclusion:\u00a0<\/b>\u00a0<\/span><\/p>\n

                                    The new EU regulation requires\u00a0transparency<\/b>,\u00a0reaction speed<\/b>\u00a0and\u00a0documented quality<\/b>. Companies are therefore faced with the task of not only making PV processes more efficient, but above all\u00a0Auditable and revision-proof<\/b>\u00a0to build.\u00a0<\/span><\/p>\n

                                    evalii\u00ae offers a solution that meets regulatory requirements\u00a0structured representation<\/b>,\u00a0Effort reduced<\/b>\u00a0and supports companies in implementing modern PV standards.\u00a0<\/span><\/p>\n

                                    With evalii\u00ae, the switch to...\u00a0modern pharmacovigilance.<\/b>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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                                    With EU Regulation 2025\/1466, key requirements for pharmacovigilance (PV) are changing significantly: The focus is shifting away from mere formalism towards traceability, process quality, and transparent documentation. For pharmaceutical companies, this means specifically that PV processes must not only function, but also be documented, versioned, and auditable along the entire process chain, from detection to corrective action. This raises expectations for the organization, IT systems, and governance alike. [\u2026]<\/p>","protected":false},"author":3,"featured_media":5114,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25,23],"tags":[29,31,28],"class_list":["post-5109","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmakovigilanz","category-rechte-regularien","tag-arzneimittelueberwachung","tag-evalii","tag-pharmakovigilanz"],"yoast_head":"\nEU-Verordnung 2025\/1466 & Pharmakovigilanz mit evalii\u00ae<\/title>\n<meta name=\"description\" content=\"Die EU-Verordnung 2025\/1466 versch\u00e4rft Anforderungen an Pharmakovigilanz. 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