Le document pr\u00e9sente un projet de \u00ab Data Quality Framework \u00bb (DQF) appliqu\u00e9 aux donn\u00e9es de pharmacovigilance dans le cadre de la r\u00e9glementation europ\u00e9enne des m\u00e9dicaments, et plus particuli\u00e8rement \u00e0 la collecte, la gestion et la transmission des d\u00e9clarations d\u2019effets ind\u00e9sirables m\u00e9dicamenteux (Adverse Drug Reactions \u2013 ADR). Il est \u00e9labor\u00e9 par le Data Analytics and Methods Task Force de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) dans le cadre du r\u00e9seau europ\u00e9en des r\u00e9gulateurs des m\u00e9dicaments (EMRN).<\/p>\n
Le texte correspond \u00e0 une version de travail (draft) dat\u00e9e du 15 octobre 2026, r\u00e9f\u00e9renc\u00e9e EMA\/87692\/2025. Il a \u00e9t\u00e9 relu par le Network Data Steering Group le 17 juillet 2026, puis amend\u00e9 pour r\u00e9pondre aux commentaires de ce groupe au 29 septembre 2026. Une consultation publique est ensuite ouverte du 19 octobre 2026 au 14 d\u00e9cembre 2026, avec recueil des contributions via un formulaire EUSurvey. Cette phase de consultation vise \u00e0 finaliser le cadre propos\u00e9 avant son \u00e9ventuelle adoption et mise en \u0153uvre.<\/p>\n
Le cadre propos\u00e9 pr\u00e9cise le champ et l\u2019objectif d\u2019un DQF d\u00e9di\u00e9 aux ADR, en contextualisant le cadre g\u00e9n\u00e9ral EMRN DQF aux sp\u00e9cificit\u00e9s des rapports d\u2019effets ind\u00e9sirables. Il s\u2019appuie sur les lignes directrices et la l\u00e9gislation en vigueur en mati\u00e8re de pharmacovigilance dans l\u2019Union europ\u00e9enne, et tient compte des terminologies sp\u00e9cifiques utilis\u00e9es pour d\u00e9crire les \u00e9v\u00e9nements ind\u00e9sirables. Il d\u00e9crit les processus et syst\u00e8mes qui sous-tendent la d\u00e9claration d\u2019ADR, notamment les dispositifs d\u2019information et de transmission vers les bases de donn\u00e9es europ\u00e9ennes, en particulier EudraVigilance et le syst\u00e8me EVVET, identifi\u00e9s comme mots-cl\u00e9s.<\/p>\n
Le document examine les caract\u00e9ristiques actuelles des donn\u00e9es ADR et les conditions de leur utilisation dans les activit\u00e9s r\u00e9glementaires. Il identifie plusieurs dimensions de la qualit\u00e9 des donn\u00e9es \u00e0 renforcer : la fiabilit\u00e9 (reliability), l\u2019exhaustivit\u00e9 (extensiveness), la coh\u00e9rence (coherence), la rapidit\u00e9 de mise \u00e0 disposition (timeliness) et la pertinence (relevance). Il pr\u00e9voit \u00e9galement des consid\u00e9rations particuli\u00e8res pour certains types ou sources de donn\u00e9es d\u2019effets ind\u00e9sirables. L\u2019ensemble vise \u00e0 am\u00e9liorer l\u2019utilisation des rapports d\u2019effets ind\u00e9sirables dans la surveillance de la s\u00e9curit\u00e9 des m\u00e9dicaments au niveau europ\u00e9en, en fournissant un cadre commun d\u2019analyse et de gestion de la qualit\u00e9 des donn\u00e9es pour les autorit\u00e9s r\u00e9glementaires du m\u00e9dicament des \u00c9tats membres et les autres acteurs du r\u00e9seau. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente un projet de \u00ab Data Quality Framework \u00bb (DQF) appliqu\u00e9 aux donn\u00e9es de pharmacovigilance dans le cadre de la r\u00e9glementation europ\u00e9enne des m\u00e9dicaments, et plus particuli\u00e8rement \u00e0 […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[36,31],"tags":[257,227,226],"class_list":["post-21436","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-droit-social-sante-travail-et-securite-sociale","category-politiques-europeennes-sante-social-travail","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21436","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21436"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21436\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}