{"id":4817,"date":"2023-06-22T10:31:07","date_gmt":"2023-06-22T08:31:07","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4817"},"modified":"2023-06-22T10:31:07","modified_gmt":"2023-06-22T08:31:07","slug":"simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/","title":{"rendered":"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs"},"content":{"rendered":"

\u00c0 partir du 22 mai 2023, les promoteurs d’essais cliniques sont soumis \u00e0 de nouvelles modalit\u00e9s simplifi\u00e9es pour la d\u00e9claration de la vigilance des m\u00e9dicaments test\u00e9s conform\u00e9ment \u00e0 la loi Jard\u00e9. Les changements apport\u00e9s sont les suivants :<\/p>\n

D\u00e9claration des effets ind\u00e9sirables graves et inattendus (EIGI) ou Suspected Unexpected Serious Adverse Reaction (SUSAR)<\/strong> : d\u00e9sormais, ces incidents doivent \u00eatre exclusivement transmis \u00e9lectroniquement \u00e0 la base de donn\u00e9es europ\u00e9enne Eudravigilance. La d\u00e9claration simultan\u00e9e \u00e0 l’Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) n’est plus requise, sauf pour les essais cliniques men\u00e9s en France sur des volontaires sains. Dans ce dernier cas, les modalit\u00e9s de d\u00e9claration \u00e0 l’ANSM via l’adresse declarationsusars@ansm.sante.fr<\/a> et \u00e0 Eudravigilance restent inchang\u00e9es.<\/p>\n

Rapports annuels de s\u00e9curit\u00e9 (RAS), Annual Safety Report (ASR) ou Development Safety Update Report (DSUR) des essais cliniques selon la loi Jard\u00e9<\/strong> : la d\u00e9claration de ces rapports doit se faire via un formulaire de d\u00e9marche simplifi\u00e9e.<\/p>\n

Ces nouvelles proc\u00e9dures visent \u00e0 simplifier le processus de d\u00e9claration des donn\u00e9es de vigilance des essais cliniques.<\/p>\n

Pour obtenir plus d’informations sur la vigilance des essais cliniques, vous pouvez consulter le lien suivant : Link<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00c0 partir du 22 mai 2023, les promoteurs d’essais cliniques sont soumis \u00e0 de nouvelles modalit\u00e9s simplifi\u00e9es pour la d\u00e9claration de la vigilance des m\u00e9dicaments test\u00e9s conform\u00e9ment \u00e0 la loi Jard\u00e9. Les changements apport\u00e9s sont les suivants : D\u00e9claration des effets ind\u00e9sirables graves et inattendus (EIGI) ou Suspected Unexpected Serious Adverse Reaction (SUSAR) : d\u00e9sormais, […]<\/p>\n","protected":false},"author":3,"featured_media":4820,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[135,151,134],"tags":[],"class_list":["post-4817","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-2","category-marketing-authorisation","category-pharmacovigilance"],"acf":[],"yoast_head":"\nSimplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs - 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\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"\u00c0 partir du 22 mai 2023, les promoteurs d’essais cliniques sont soumis \u00e0 de nouvelles modalit\u00e9s simplifi\u00e9es pour la d\u00e9claration de la vigilance des m\u00e9dicaments test\u00e9s conform\u00e9ment \u00e0 la loi Jard\u00e9. Les changements apport\u00e9s sont les suivants : D\u00e9claration des effets ind\u00e9sirables graves et inattendus (EIGI) ou Suspected Unexpected Serious Adverse Reaction (SUSAR) : d\u00e9sormais, […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/\" \/>\n<meta property=\"og:site_name\" content=\"Universal Medica\" \/>\n<meta property=\"article:published_time\" content=\"2023-06-22T08:31:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2023\/06\/2_3.png\" \/>\n\t<meta property=\"og:image:width\" content=\"500\" \/>\n\t<meta property=\"og:image:height\" content=\"300\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Gobi Nathan\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Gobi Nathan\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/\"},\"author\":{\"name\":\"Gobi Nathan\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#\\\/schema\\\/person\\\/45029bc39741cfb27831e6380f0b218e\"},\"headline\":\"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs\",\"datePublished\":\"2023-06-22T08:31:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/\"},\"wordCount\":231,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/2_3.png\",\"articleSection\":[\"Compliance\",\"Marketing authorisation\",\"Pharmacovigilance\"],\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/\",\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/\",\"name\":\"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs - Universal Medica\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/2_3.png\",\"datePublished\":\"2023-06-22T08:31:07+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/#\\\/schema\\\/person\\\/45029bc39741cfb27831e6380f0b218e\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/2_3.png\",\"contentUrl\":\"https:\\\/\\\/www.universalmedica.com\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/2_3.png\",\"width\":500,\"height\":300},{\"@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\\\/45029bc39741cfb27831e6380f0b218e\",\"name\":\"Gobi Nathan\",\"url\":\"https:\\\/\\\/www.universalmedica.com\\\/fr\\\/author\\\/gobi-nathanuniversalmedica-com\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs - 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\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/","og_locale":"fr_FR","og_type":"article","og_title":"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs - Universal Medica","og_description":"\u00c0 partir du 22 mai 2023, les promoteurs d’essais cliniques sont soumis \u00e0 de nouvelles modalit\u00e9s simplifi\u00e9es pour la d\u00e9claration de la vigilance des m\u00e9dicaments test\u00e9s conform\u00e9ment \u00e0 la loi Jard\u00e9. Les changements apport\u00e9s sont les suivants : D\u00e9claration des effets ind\u00e9sirables graves et inattendus (EIGI) ou Suspected Unexpected Serious Adverse Reaction (SUSAR) : d\u00e9sormais, […]","og_url":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/","og_site_name":"Universal Medica","article_published_time":"2023-06-22T08:31:07+00:00","og_image":[{"width":500,"height":300,"url":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2023\/06\/2_3.png","type":"image\/png"}],"author":"Gobi Nathan","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"Gobi Nathan","Dur\u00e9e de lecture estim\u00e9e":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/#article","isPartOf":{"@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/"},"author":{"name":"Gobi Nathan","@id":"https:\/\/www.universalmedica.com\/fr\/#\/schema\/person\/45029bc39741cfb27831e6380f0b218e"},"headline":"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs","datePublished":"2023-06-22T08:31:07+00:00","mainEntityOfPage":{"@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/"},"wordCount":231,"commentCount":0,"image":{"@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/#primaryimage"},"thumbnailUrl":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2023\/06\/2_3.png","articleSection":["Compliance","Marketing authorisation","Pharmacovigilance"],"inLanguage":"fr-FR","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/","url":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/","name":"Simplification des modalit\u00e9s de d\u00e9claration pour la surveillance de la s\u00e9curit\u00e9 des essais cliniques : des d\u00e9marches simplifi\u00e9es pour les promoteurs - Universal Medica","isPartOf":{"@id":"https:\/\/www.universalmedica.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/#primaryimage"},"image":{"@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/#primaryimage"},"thumbnailUrl":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2023\/06\/2_3.png","datePublished":"2023-06-22T08:31:07+00:00","author":{"@id":"https:\/\/www.universalmedica.com\/fr\/#\/schema\/person\/45029bc39741cfb27831e6380f0b218e"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/www.universalmedica.com\/fr\/simplification-des-modalites-de-declaration-pour-la-surveillance-de-la-securite-des-essais-cliniques-des-demarches-simplifiees-pour-les-promoteurs\/#primaryimage","url":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2023\/06\/2_3.png","contentUrl":"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2023\/06\/2_3.png","width":500,"height":300},{"@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\/45029bc39741cfb27831e6380f0b218e","name":"Gobi Nathan","url":"https:\/\/www.universalmedica.com\/fr\/author\/gobi-nathanuniversalmedica-com\/"}]}},"_links":{"self":[{"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts\/4817","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/comments?post=4817"}],"version-history":[{"count":1,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts\/4817\/revisions"}],"predecessor-version":[{"id":4824,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/posts\/4817\/revisions\/4824"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/media\/4820"}],"wp:attachment":[{"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/media?parent=4817"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/categories?post=4817"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.universalmedica.com\/fr\/wp-json\/wp\/v2\/tags?post=4817"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}