{"id":57879,"date":"2026-02-26T02:07:09","date_gmt":"2026-02-26T01:07:09","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/notification-devenements-indesirables-graves-et-traitement-des-cas\/"},"modified":"2026-02-26T02:07:09","modified_gmt":"2026-02-26T01:07:09","slug":"notification-devenements-indesirables-graves-et-traitement-des-cas","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/notification-devenements-indesirables-graves-et-traitement-des-cas\/","title":{"rendered":"Notification d\u2019\u00e9v\u00e9nements ind\u00e9sirables graves et traitement des cas"},"content":{"rendered":"<p>Les <a href=\"https:\/\/www.fda.gov\/safety\/reporting-serious-problems-fda\/what-serious-adverse-event\">\u00e9v\u00e9nements ind\u00e9sirables graves<\/a> (EIG) sont des signaux de s\u00e9curit\u00e9 critiques dans la recherche clinique. Les r\u00e9gulateurs, les comit\u00e9s d\u2019\u00e9thique et les promoteurs comptent sur une notification rapide et pr\u00e9cise pour d\u00e9tecter les risques, prot\u00e9ger les participants et maintenir l\u2019int\u00e9grit\u00e9 de l\u2019\u00e9tude. Un signalement tardif ou incoh\u00e9rent peut mettre les patients en danger et entra\u00eener des probl\u00e8mes de conformit\u00e9 majeurs.  <\/p>\n<p>Ce cours fournit une base claire et pratique pour l\u2019identification, l\u2019\u00e9valuation, la documentation et la notification des EIG. Vous apprendrez comment la gravit\u00e9 est d\u00e9termin\u00e9e, comment le caract\u00e8re attendu et la causalit\u00e9 influencent les d\u00e9lais de notification acc\u00e9l\u00e9r\u00e9e, et comment les cadres r\u00e9glementaires mondiaux guident les responsabilit\u00e9s des promoteurs et des investigateurs. <\/p>\n<p>Con\u00e7ue pour les op\u00e9rations cliniques r\u00e9elles, cette formation vous donne les outils pour g\u00e9rer les processus d\u2019EIG avec assurance et en toute conformit\u00e9.<\/p>\n<p>Une fois la formation r\u00e9ussie, vous recevrez un <strong>certificat valid\u00e9<\/strong> accr\u00e9dit\u00e9 par des cr\u00e9dits CPD\/CEU, adapt\u00e9 \u00e0 la documentation d\u2019audit et de conformit\u00e9.<\/p>\n<p><strong>\u00c0 qui s\u2019adresse ce cours ?<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Ce cours est id\u00e9al pour les professionnels impliqu\u00e9s dans les essais cliniques, le suivi de la s\u00e9curit\u00e9 et la <\/span><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/pharmacocinetique-et-pharmacodynamie-pour-debutants-et-professionnels\/\"><span style=\"font-weight: 400;\">pharmacovigilance<\/span><\/a><span style=\"font-weight: 400;\">, notamment :<\/span><\/p>\n<ul>\n<li><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/attache-de-recherche-clinique-arc\/\"><span style=\"font-weight: 400;\">Attach\u00e9s de recherche clinique<\/span><\/a><span style=\"font-weight: 400;\"> (ARC) et coordinateurs<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Investigateurs d\u2019<\/span><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/essais-cliniques-bpc\/\"><span style=\"font-weight: 400;\">essais cliniques<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Professionnels des<\/span> <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/specialiste-des-affaires-reglementaires\/\"><span style=\"font-weight: 400;\">affaires r\u00e9glementaires<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Personnel des promoteurs et des <\/span><a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/organisme-de-recherche-sous-contrat-cro\/\"><span style=\"font-weight: 400;\">CRO<\/span><\/a><span style=\"font-weight: 400;\"> responsable de la notification des EIG et du traitement des cas<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00c9quipes d\u2019assurance qualit\u00e9 et d\u2019<\/span><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/audit-bpf-interne-role-de-lauditeur-bpf\/\"><span style=\"font-weight: 400;\">audit interne<\/span><\/a><span style=\"font-weight: 400;\"> soutenant les essais cliniques<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Qu\u2019allez-vous apprendre ?<\/strong><\/p>\n<ul>\n<li>Comprendre l\u2019importance de la notification des EIG pour la s\u00e9curit\u00e9 des patients et la conformit\u00e9 r\u00e9glementaire<\/li>\n<li>Diff\u00e9rencier les \u00e9v\u00e9nements ind\u00e9sirables (EI) des EIG, y compris la gravit\u00e9, l\u2019intensit\u00e9, le caract\u00e8re attendu et la causalit\u00e9<\/li>\n<li>Appliquer les crit\u00e8res pour d\u00e9terminer quand un EI est qualifi\u00e9 d\u2019EIG, y compris les cas limites ou m\u00e9dicalement importants<\/li>\n<li>Expliquer les r\u00f4les et responsabilit\u00e9s des investigateurs, promoteurs et CRO dans l\u2019identification, la notification et le suivi des EIG<\/li>\n<li>Naviguer dans le cycle de vie de la notification des EIG, y compris les d\u00e9lais, la documentation et la surveillance de la qualit\u00e9<\/li>\n<\/ul>\n<h3>Programme :<\/h3>\n<p>Le\u00e7on 1 : Introduction aux \u00e9v\u00e9nements ind\u00e9sirables graves<br \/>\nLe\u00e7on 2 : Crit\u00e8res de d\u00e9termination de la gravit\u00e9 d\u2019un EI<br \/>\nLe\u00e7on 3 : R\u00f4les et responsabilit\u00e9s des parties prenantes dans la notification des EIG<br \/>\nLe\u00e7on 4 : Processus et d\u00e9lais de notification des EIG<br \/>\nLe\u00e7on 5 : Traitement des cas d\u2019EIG et documentation<br \/>\nLe\u00e7on 6 : Gestion des situations particuli\u00e8res en tant qu\u2019EIG<br \/>\nLe\u00e7on 7 : Surveillance de la qualit\u00e9, audits et pr\u00e9paration aux inspections<br \/>\nConclusion<br \/>\n\u00c9valuation<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les \u00e9v\u00e9nements ind\u00e9sirables graves (EIG) sont des signaux de s\u00e9curit\u00e9 critiques dans la recherche clinique. Les r\u00e9gulateurs, les comit\u00e9s d\u2019\u00e9thique et les promoteurs comptent sur une notification rapide et pr\u00e9cise pour d\u00e9tecter les risques, prot\u00e9ger les participants et maintenir l\u2019int\u00e9grit\u00e9 de l\u2019\u00e9tude. Un signalement tardif ou incoh\u00e9rent peut mettre les patients en danger et entra\u00eener [&hellip;]<\/p>\n","protected":false},"featured_media":55021,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,264],"product_tag":[],"class_list":{"0":"post-57879","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-transversal","9":"first","10":"instock","11":"taxable","12":"shipping-taxable","13":"purchasable","14":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cours certifi\u00e9 sur la notification des \u00e9v\u00e9nements ind\u00e9sirables graves (EIG)<\/title>\n<meta name=\"description\" content=\"Formation certifi\u00e9e sur la notification des EIG pour les \u00e9quipes d\u2019essais cliniques et de pharmacovigilance. 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