Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne situ\u00e9e \u00e0 Amsterdam. Il s\u2019agit de la version 2.2, dat\u00e9e du 31 ao\u00fbt 2026, du manuel utilisateur relatif \u00e0 l\u2019acc\u00e8s en ligne, via le portail adrreports.eu, \u00e0 EudraVigilance, la base de donn\u00e9es europ\u00e9enne des suspicions d\u2019effets ind\u00e9sirables associ\u00e9s aux m\u00e9dicaments. La reproduction du document est autoris\u00e9e sous r\u00e9serve de mentionner la source.<\/p>\n
EudraVigilance est pr\u00e9sent\u00e9e comme la base de donn\u00e9es centralisant au niveau europ\u00e9en les cas individuels de suspicions d\u2019effets ind\u00e9sirables. Le manuel d\u00e9crit l\u2019acc\u00e8s en ligne pour la consultation de rapports agr\u00e9g\u00e9s (tableaux de bord) sur ces cas. Il pr\u00e9cise les \u00e9l\u00e9ments de donn\u00e9es utilis\u00e9s dans ces rapports, ainsi que des r\u00e8gles de gestion des informations lorsqu\u2019un m\u00eame cas comporte plusieurs d\u00e9clarants ou plusieurs effets ind\u00e9sirables avec des issues diff\u00e9rentes. Ces r\u00e8gles influent sur le d\u00e9compte et la pr\u00e9sentation statistique des cas.<\/p>\n
Le contenu du manuel est structur\u00e9 autour de plusieurs rubriques : informations g\u00e9n\u00e9rales de contexte, avertissement (disclaimer), description d\u00e9taill\u00e9e des \u00e9l\u00e9ments de donn\u00e9es, et modalit\u00e9s de mise en forme des rapports. La partie consacr\u00e9e \u00e0 la mise en forme d\u00e9crit plusieurs onglets de consultation : nombre total de cas individuels, nombre de cas re\u00e7us dans le temps, r\u00e9partition des cas par pays de l\u2019Espace \u00e9conomique europ\u00e9en (EEE), par groupe de r\u00e9actions, puis par r\u00e9action s\u00e9lectionn\u00e9e. Un onglet sp\u00e9cifique pr\u00e9sente une \u00ab line listing \u00bb permettant un affichage plus d\u00e9taill\u00e9 des cas. Une section traite de l\u2019interpr\u00e9tation de ces rapports web et une autre des fonctionnalit\u00e9s de navigation g\u00e9n\u00e9rales dans l\u2019outil.<\/p>\n
Les acteurs mentionn\u00e9s sont l\u2019Agence europ\u00e9enne des m\u00e9dicaments, responsable du dispositif et de sa mise \u00e0 disposition publique, et, de mani\u00e8re implicite, les \u00c9tats de l\u2019EEE \u00e0 travers les ventilations par pays. Le dispositif vise \u00e0 mettre \u00e0 disposition des donn\u00e9es harmonis\u00e9es de pharmacovigilance au niveau europ\u00e9en, avec un acc\u00e8s ouvert via un portail d\u00e9di\u00e9. Le manuel souligne, par la pr\u00e9sence d\u2019un avertissement, l\u2019existence de limites et de pr\u00e9cautions d\u2019interpr\u00e9tation des donn\u00e9es, sans d\u00e9tailler celles-ci dans l\u2019extrait disponible.<\/p>\n
Pour les administrations publiques, ce document indique qu\u2019au niveau de l\u2019Union europ\u00e9enne existe un syst\u00e8me structur\u00e9 de rapports agr\u00e9g\u00e9s sur les suspicions d\u2019effets ind\u00e9sirables des m\u00e9dicaments, accessible en ligne, avec des fonctionnalit\u00e9s de suivi dans le temps, par pays de l\u2019EEE et par type de r\u00e9action. Ces informations peuvent \u00eatre exploit\u00e9es pour la surveillance des produits de sant\u00e9 et la comparaison internationale, dans la limite des pr\u00e9cautions d\u2019interpr\u00e9tation pr\u00e9cis\u00e9es par l\u2019EMA. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne situ\u00e9e \u00e0 Amsterdam. Il s\u2019agit de la version 2.2, dat\u00e9e du 31 ao\u00fbt 2026, du manuel utilisateur […]<\/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-17737","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\/17737","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=17737"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17737\/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=17737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}