{"id":7480,"date":"2026-02-17T10:57:07","date_gmt":"2026-02-17T09:57:07","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=7480"},"modified":"2026-02-17T15:55:22","modified_gmt":"2026-02-17T14:55:22","slug":"y-a-t-il-un-signal-sur-la-gestion-du-signal","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/y-a-t-il-un-signal-sur-la-gestion-du-signal\/","title":{"rendered":"Y a-t-il un signal sur la gestion du signal ?"},"content":{"rendered":"\t\t
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1. Objectifs communs<\/strong><\/h2>

Les deux documents partagent des finalit\u00e9s similaires :<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Point<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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EMA (FAQ Signal Management 2026)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Swissmedic (Guide Signal 2026)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Convergence<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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D\u00e9tection de signaux<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Clarification de l\u2019int\u00e9gration d\u2019EudraVigilance comme source principale (non obligatoire \u00e0 la phase de d\u00e9tection sous r\u00e9serve d\u2019une analyse de risque document\u00e9e)<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Clarification quant \u00e0 la mani\u00e8re d\u2019identifier et de notifier les signaux de s\u00e9curit\u00e9<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Les deux renforcent l\u2019importance de l\u2019identification proactive des signaux<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\u00c9valuation des signaux<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Int\u00e9gration d\u2019EVDAS dans les phases de validation et d\u2019analyse
Insistance sur la documentation des d\u00e9cisions de signal management, tra\u00e7abilit\u00e9 et justification des actions\/non-actions<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Pr\u00e9cision quant au contenu attendu des rapports de signal et d\u00e9finitions des annexes requises<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Les deux soulignent la n\u00e9cessit\u00e9 d\u2019une documentation compl\u00e8te et tra\u00e7able<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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R\u00f4le du titulaire \/ QPPV<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Le titulaire reste responsable, supervise les prestataires, valide les actions et assure la conformit\u00e9<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Le titulaire d\u2019AMM ou fabricant est responsable de la notification compl\u00e8te et correcte du signal<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Convergence forte sur la responsabilit\u00e9 du titulaire d\u2019AMM<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Documentation et conformit\u00e9<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Toutes les actions de signal management doivent \u00eatre auditables et conformes au GVP<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Formulaire et guide permettent d\u2019assurer la conformit\u00e9 lors des inspections<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Les deux exigent un niveau similaire de formalisme et tra\u00e7abilit\u00e9<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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2. Diff\u00e9rences principales<\/strong><\/h2>
  • Format et proc\u00e9dure :<\/strong>
    • EMA : int\u00e9gration dans le r\u00e9seau EudraVigilance, liens avec PRAC, approche harmonis\u00e9e europ\u00e9enne.<\/li>
    • Swissmedic : formulaire sp\u00e9cifique (Signal Notification Form) et guide national, avec quelques particularit\u00e9s suisses (ex. contenu pr\u00e9cis pour notifications locales).<\/li><\/ul><\/li>
    • Cadre r\u00e9glementaire :<\/strong>
      • EMA : align\u00e9 sur le R\u00e8glement (UE) 2025\/1466 et GVP IX.<\/li>
      • Swissmedic : align\u00e9 sur la l\u00e9gislation suisse sur les m\u00e9dicaments (LPM\u00e9d \/ TPA), avec des sp\u00e9cificit\u00e9s pour notifications locales et suivi interne.<\/li><\/ul><\/li>
      • Port\u00e9e des sources de donn\u00e9es :<\/strong>
        • EMA : EudraVigilance + litt\u00e9rature + donn\u00e9es multi-pays.<\/li>
        • Swissmedic : donn\u00e9es internes, rapports de cas et informations re\u00e7ues depuis l\u2019\u00e9tranger, mais pas d\u2019acc\u00e8s direct \u00e0 EudraVigilance (sauf via soumission volontaire par MAH).<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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          3. Conclusion<\/strong><\/h2>

          M\u00eame si les d\u00e9tails op\u00e9rationnels diff\u00e8rent, il y a une convergence forte sur<\/strong> :<\/p>

          1. Responsabilit\u00e9 centrale du titulaire d\u2019AMM<\/strong> pour superviser et valider les signaux.<\/li>
          2. N\u00e9cessit\u00e9 de documentation compl\u00e8te et tra\u00e7able<\/strong> pour chaque signal.<\/li>
          3. Clart\u00e9 sur le contenu et la structure des rapports de signal<\/strong> (EMA : via GVP IX et FAQ; Swissmedic : via guide et formulaire).<\/li>
          4. Renforcement de la gouvernance et des contr\u00f4les internes<\/strong>, surtout dans des contextes d\u2019externalisation ou d\u2019int\u00e9gration de multiples sources de donn\u00e9es.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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            En pratique, un MAH op\u00e9rant en Europe et en Suisse peut harmoniser ses processus de signal management<\/strong> pour r\u00e9pondre aux deux exigences, en adaptant seulement le format et certaines modalit\u00e9s sp\u00e9cifiques \u00e0 chaque juridiction.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

            1. Objectifs communs Les deux documents partagent des finalit\u00e9s similaires : Point EMA (FAQ Signal Management 2026) Swissmedic (Guide Signal 2026) Convergence D\u00e9tection de signaux Clarification de l\u2019int\u00e9gration d\u2019EudraVigilance comme source principale (non obligatoire \u00e0 la phase de d\u00e9tection sous r\u00e9serve d\u2019une analyse de risque document\u00e9e) Clarification quant \u00e0 la mani\u00e8re d\u2019identifier et de notifier […]<\/p>\n","protected":false},"author":2,"featured_media":7495,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[134],"tags":[],"class_list":["post-7480","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmacovigilance"],"acf":[],"yoast_head":"\nY a-t-il un signal sur la gestion du signal ? - Universal Medica<\/title>\n<meta name=\"description\" content=\"L\u2019EMA a publi\u00e9 ses FAQ r\u00e9vis\u00e9es sur la gestion du signal. 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