{"id":936,"date":"2017-08-04T08:16:18","date_gmt":"2017-08-04T06:16:18","guid":{"rendered":"http:\/\/www.universalmedica.com\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/"},"modified":"2021-05-19T17:09:21","modified_gmt":"2021-05-19T15:09:21","slug":"nouvelles-fonctionnalites-du-systeme-eudravigilance","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/","title":{"rendered":"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance"},"content":{"rendered":"<p>\u00c0 partir du 22 novembre 2017, <strong>EudraVigilance<\/strong>, la base de donn\u00e9es des rapports sur les effets ind\u00e9sirables li\u00e9s \u00e0 l\u2019utilisation des m\u00e9dicaments va conna\u00eetre une mise \u00e0 jour. L\u2019EMA (<em>European Medicines Agency<\/em>) collecte \u00e0 travers ce site les d\u00e9clarations soumises par les autorit\u00e9s comp\u00e9tentes et les titulaires d&rsquo;autorisation de mise sur le march\u00e9. Le grand public peut acc\u00e9der aux donn\u00e9es soumises depuis 2012 et ce, dans le but de renforcer la transparence sur les b\u00e9n\u00e9fices et les risques d\u2019utilisation des m\u00e9dicaments.<\/p>\n<h2>EudraVigilance<\/h2>\n<p>EudraVigilance est un syst\u00e8me utilis\u00e9 depuis 2011 pour collecter notamment les d\u00e9clarations de cas de pharmacovigilance. Ces d\u00e9clarations permettent \u00e0 l\u2019Agence d\u2019\u00e9valuer la s\u00e9curit\u00e9 des m\u00e9dicaments pendant leur d\u00e9veloppement et apr\u00e8s leur autorisation dans l\u2019Espace Economique Europ\u00e9en.<\/p>\n<p>Les rapports pr\u00e9sents sur le site sont soumis par les autorit\u00e9s sanitaires des pays europ\u00e9ens, les entreprises pharmaceutiques ainsi que les promoteurs des essais cliniques.<\/p>\n<h2>B\u00e9n\u00e9fices du nouveau syst\u00e8me EudraVigilance<\/h2>\n<p>Avec la mise \u00e0 jour de la loi europ\u00e9enne sur la pharmacovigilance, l\u2019EMA lancera en novembre de nouvelles fonctionnalit\u00e9s dans son syst\u00e8me Eudravigilance :<br \/>\n &#8211; Une meilleure d\u00e9tection de nouveaux signaux de pharmacovigilance gr\u00e2ce \u00e0 un outil d\u2019analyse plus performant permettra une prise de d\u00e9cision plus rapide pour prot\u00e9ger la sant\u00e9 des citoyens europ\u00e9ens ;<br \/>\n &#8211; Des d\u00e9clarations de cas PV plus compl\u00e8tes et facilement analysables ;<br \/>\n &#8211; Un champ d\u2019application plus large ; le syst\u00e8me recevra \u00e9galement les d\u00e9clarations de tous les <em>cas non graves<\/em><sup>[1]<\/sup> ;<br \/>\n &#8211; Des proc\u00e9dures de d\u00e9claration plus simplifi\u00e9es<sup>[2]<\/sup> pour les laboratoires qui ne soumettront les d\u00e9clarations que dans EudraVigilance uniquement ;<br \/>\n &#8211; Une meilleure collaboration entre l\u2019EMA et l\u2019OMS (Organisation Mondiale de la Sant\u00e9) par la transmission de donn\u00e9es directement \u00e0 travers EudraVigilance.<\/p>\n<hr\/>\n<p>&#8211; [1] Pendant la p\u00e9riode d\u2019int\u00e9rim, certains <em>ICSRs<\/em> (Individual Case Safety Reports) non graves devaient \u00eatre soumis, en fonction du pays (ex : Allemagne et les vaccins).<br \/>\n&#8211; [2] Pendant la p\u00e9riode d\u2019int\u00e9rim, on soumettait la plupart des ICSRs dans EudraVigilance mais l\u2019Europe n\u2019\u00e9tait pas forc\u00e9ment le destinataire : les autorit\u00e9s nationales pouvaient \u00eatre les destinataires, en utilisant EV pour soumettre le cas.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00c0 partir du 22 novembre 2017, EudraVigilance, la base de donn\u00e9es des rapports sur les effets ind\u00e9sirables li\u00e9s \u00e0 l\u2019utilisation des m\u00e9dicaments va conna\u00eetre une mise \u00e0 jour. L\u2019EMA (European Medicines Agency) collecte \u00e0 travers ce site les d\u00e9clarations soumises par les autorit\u00e9s comp\u00e9tentes et les titulaires d&rsquo;autorisation de mise sur le march\u00e9. Le grand [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":663,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[134],"tags":[38,39,40],"class_list":["post-936","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmacovigilance","tag-eudravigilance","tag-medicament","tag-pharmacovigilance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance - Universal Medica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"\u00c0 partir du 22 novembre 2017, EudraVigilance, la base de donn\u00e9es des rapports sur les effets ind\u00e9sirables li\u00e9s \u00e0 l\u2019utilisation des m\u00e9dicaments va conna\u00eetre une mise \u00e0 jour. L\u2019EMA (European Medicines Agency) collecte \u00e0 travers ce site les d\u00e9clarations soumises par les autorit\u00e9s comp\u00e9tentes et les titulaires d&rsquo;autorisation de mise sur le march\u00e9. Le grand [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/\" \/>\n<meta property=\"og:site_name\" content=\"Universal Medica\" \/>\n<meta property=\"article:published_time\" content=\"2017-08-04T06:16:18+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-05-19T15:09:21+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/surveillance-medicament.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"790\" \/>\n\t<meta property=\"og:image:height\" content=\"361\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/\"},\"author\":{\"name\":\"Admin\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#\\\/schema\\\/person\\\/6310cfd59ccce9f9d4bc94d081892a84\"},\"headline\":\"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance\",\"datePublished\":\"2017-08-04T06:16:18+00:00\",\"dateModified\":\"2021-05-19T15:09:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/\"},\"wordCount\":392,\"image\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/surveillance-medicament.jpg\",\"keywords\":[\"EudraVigilance\",\"m\u00e9dicament\",\"pharmacovigilance\"],\"articleSection\":[\"Pharmacovigilance\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/\",\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/\",\"name\":\"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance - Universal Medica\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/surveillance-medicament.jpg\",\"datePublished\":\"2017-08-04T06:16:18+00:00\",\"dateModified\":\"2021-05-19T15:09:21+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#\\\/schema\\\/person\\\/6310cfd59ccce9f9d4bc94d081892a84\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/nouvelles-fonctionnalites-du-systeme-eudravigilance\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/surveillance-medicament.jpg\",\"contentUrl\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/surveillance-medicament.jpg\",\"width\":790,\"height\":361,\"caption\":\"pharmacovigilance\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/\",\"name\":\"Universal Medica\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#\\\/schema\\\/person\\\/6310cfd59ccce9f9d4bc94d081892a84\",\"name\":\"Admin\",\"sameAs\":[\"http:\\\/\\\/universalmedica.agencekonig.com\"],\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/author\\\/admin\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance - Universal Medica","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/","og_locale":"fr_FR","og_type":"article","og_title":"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance - Universal Medica","og_description":"\u00c0 partir du 22 novembre 2017, EudraVigilance, la base de donn\u00e9es des rapports sur les effets ind\u00e9sirables li\u00e9s \u00e0 l\u2019utilisation des m\u00e9dicaments va conna\u00eetre une mise \u00e0 jour. L\u2019EMA (European Medicines Agency) collecte \u00e0 travers ce site les d\u00e9clarations soumises par les autorit\u00e9s comp\u00e9tentes et les titulaires d&rsquo;autorisation de mise sur le march\u00e9. Le grand [&hellip;]","og_url":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/","og_site_name":"Universal Medica","article_published_time":"2017-08-04T06:16:18+00:00","article_modified_time":"2021-05-19T15:09:21+00:00","og_image":[{"width":790,"height":361,"url":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/surveillance-medicament.jpg","type":"image\/jpeg"}],"author":"Admin","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"Admin","Dur\u00e9e de lecture estim\u00e9e":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/#article","isPartOf":{"@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/"},"author":{"name":"Admin","@id":"https:\/\/www.universalmedica.com\/fr\/#\/schema\/person\/6310cfd59ccce9f9d4bc94d081892a84"},"headline":"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance","datePublished":"2017-08-04T06:16:18+00:00","dateModified":"2021-05-19T15:09:21+00:00","mainEntityOfPage":{"@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/"},"wordCount":392,"image":{"@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/#primaryimage"},"thumbnailUrl":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/surveillance-medicament.jpg","keywords":["EudraVigilance","m\u00e9dicament","pharmacovigilance"],"articleSection":["Pharmacovigilance"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/","url":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/","name":"Les nouvelles fonctionnalit\u00e9s du syst\u00e8me EudraVigilance - Universal Medica","isPartOf":{"@id":"https:\/\/www.universalmedica.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/#primaryimage"},"image":{"@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/#primaryimage"},"thumbnailUrl":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/surveillance-medicament.jpg","datePublished":"2017-08-04T06:16:18+00:00","dateModified":"2021-05-19T15:09:21+00:00","author":{"@id":"https:\/\/www.universalmedica.com\/fr\/#\/schema\/person\/6310cfd59ccce9f9d4bc94d081892a84"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/www.universalmedica.com\/fr\/nouvelles-fonctionnalites-du-systeme-eudravigilance\/#primaryimage","url":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/surveillance-medicament.jpg","contentUrl":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/surveillance-medicament.jpg","width":790,"height":361,"caption":"pharmacovigilance"},{"@type":"WebSite","@id":"https:\/\/www.universalmedica.com\/fr\/#website","url":"https:\/\/www.universalmedica.com\/fr\/","name":"Universal Medica","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.universalmedica.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Person","@id":"https:\/\/www.universalmedica.com\/fr\/#\/schema\/person\/6310cfd59ccce9f9d4bc94d081892a84","name":"Admin","sameAs":["http:\/\/universalmedica.agencekonig.com"],"url":"https:\/\/www.universalmedica.com\/fr\/author\/admin\/"}]}},"_links":{"self":[{"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts\/936","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/comments?post=936"}],"version-history":[{"count":1,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts\/936\/revisions"}],"predecessor-version":[{"id":2795,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts\/936\/revisions\/2795"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/media\/663"}],"wp:attachment":[{"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/media?parent=936"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/categories?post=936"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/tags?post=936"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}