{"id":57367,"date":"2022-05-24T10:36:29","date_gmt":"2022-05-24T08:36:29","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gestion-des-cas-de-pharmacovigilance\/"},"modified":"2022-05-24T10:36:29","modified_gmt":"2022-05-24T08:36:29","slug":"gestion-des-cas-de-pharmacovigilance","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/gestion-des-cas-de-pharmacovigilance\/","title":{"rendered":"Gestion des cas de pharmacovigilance"},"content":{"rendered":"<p>Une fois qu\u2019un m\u00e9dicament ou un dispositif m\u00e9dical est mis sur le march\u00e9, la surveillance de la s\u00e9curit\u00e9 devient une obligation r\u00e9glementaire continue. La gestion des cas de pharmacovigilance est au c\u0153ur de ce syst\u00e8me, et la qualit\u00e9 de chaque cas a un impact direct sur les r\u00e9sultats de la surveillance post-commercialisation. <\/p>\n<p>D\u00e9velopp\u00e9 par des experts en affaires r\u00e9glementaires titulaires de qualifications de la Northeastern University, Boston, ce cours fournit aux professionnels les connaissances n\u00e9cessaires pour traiter les cas de pharmacovigilance avec pr\u00e9cision et conform\u00e9ment aux attentes r\u00e9glementaires.<\/p>\n<p>\u00c0 l\u2019issue de la formation, vous recevrez un <strong>certificat valid\u00e9 accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, reconnu \u00e0 des fins d\u2019audit et de conformit\u00e9.<\/p>\n<p><strong>Qui devrait s\u2019inscrire ?<\/strong><\/p>\n<ul>\n<li>Professionnels de la <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/pharmacovigilance\/\">pharmacovigilance<\/a> et de la s\u00e9curit\u00e9 des m\u00e9dicaments<\/li>\n<li>Sp\u00e9cialistes des <a href=\"https:\/\/gxp-training.com\/online-course\/regulatory-affairs-specialist-training-certification\/\">affaires r\u00e9glementaires<\/a> impliqu\u00e9s dans la d\u00e9claration de s\u00e9curit\u00e9<\/li>\n<li>Personnel de la <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpc-essais-cliniques\/\">recherche clinique<\/a> et des affaires m\u00e9dicales<\/li>\n<li>Professionnels de l\u2019<a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/assurance-qualite\/\">assurance qualit\u00e9<\/a> soutenant les op\u00e9rations de pharmacovigilance<\/li>\n<\/ul>\n<p><strong>Ce que vous apprendrez ?<\/strong><\/p>\n<ul>\n<li>Le p\u00e9rim\u00e8tre et l\u2019importance de la <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/good-pharmacovigilance-practices-gvp\">pharmacovigilance<\/a> dans la surveillance de la s\u00e9curit\u00e9 post-commercialisation<\/li>\n<li>Comment recevoir, valider et assurer le suivi des notifications de cas<\/li>\n<li>Proc\u00e9dures de triage, recherche de doublons, saisie des donn\u00e9es et \u00e9valuation du codage<\/li>\n<li>Pratiques de gestion de la qualit\u00e9 et erreurs courantes dans la gestion des cas<\/li>\n<li><a href=\"https:\/\/www.fda.gov\/drugs\/cder-conversations\/understanding-cders-postmarket-safety-surveillance-programs-and-public-data\">Exigences de soumission r\u00e9glementaire<\/a> et d\u00e9lais pour les rapports de s\u00e9curit\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p><strong>Introduction<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : Pharmacovigilance et gestion des cas de pharmacovigilance : importance et principales \u00e9tapes<\/strong><\/p>\n<ul>\n<li>Qu\u2019est-ce que la <a href=\"https:\/\/gxp-training.com\/fr\/pharmacovigilance\/la-pharmacovigilance-et-son-importance-en-sante-publique\/\">pharmacovigilance<\/a> ?<\/li>\n<li>Pourquoi la pharmacovigilance est-elle n\u00e9cessaire ?<\/li>\n<li>Bonnes pratiques de pharmacovigilance<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 2 : Collecte des donn\u00e9es \u2013 r\u00e9ception et validation d\u2019une notification de cas<\/strong><\/p>\n<ul>\n<li>Sources des notifications<\/li>\n<li>R\u00e9ception des donn\u00e9es<\/li>\n<li>Validation des notifications<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 3 : Collecte des donn\u00e9es dans des situations particuli\u00e8res<\/strong><\/p>\n<ul>\n<li>Grossesse ou allaitement<\/li>\n<li>Population p\u00e9diatrique<\/li>\n<li>Mauvaise utilisation, abus ou surdosage du m\u00e9dicament<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 4 : Triage, saisie des donn\u00e9es et \u00e9valuation<\/strong><\/p>\n<ul>\n<li>Triage<\/li>\n<li>Recherche de doublons<\/li>\n<li>Saisie compl\u00e8te des donn\u00e9es<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 5 : Maintenir la qualit\u00e9 et \u00e9viter les erreurs dans la gestion des cas<\/strong><\/p>\n<ul>\n<li>Gestion de la qualit\u00e9<\/li>\n<li>Erreurs dans la gestion des cas<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 6 : Transmission aux autorit\u00e9s et actions ult\u00e9rieures<\/strong><\/p>\n<ul>\n<li>Soumission des rapports de s\u00e9curit\u00e9<\/li>\n<li>D\u00e9lais de soumission<\/li>\n<li>Retrait du march\u00e9<\/li>\n<\/ul>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Une fois qu\u2019un m\u00e9dicament ou un dispositif m\u00e9dical est mis sur le march\u00e9, la surveillance de la s\u00e9curit\u00e9 devient une obligation r\u00e9glementaire continue. La gestion des cas de pharmacovigilance est au c\u0153ur de ce syst\u00e8me, et la qualit\u00e9 de chaque cas a un impact direct sur les r\u00e9sultats de la surveillance post-commercialisation. D\u00e9velopp\u00e9 par des [&hellip;]<\/p>\n","protected":false},"featured_media":43768,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[258,267],"product_tag":[],"class_list":{"0":"post-57367","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-pharmaceutique","7":"product_cat-pharmacovigilance","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>Formation en ligne sur la gestion et la d\u00e9claration des cas de pharmacovigilance<\/title>\n<meta name=\"description\" content=\"En savoir plus sur notre cours en ligne certifi\u00e9 de gestion et de d\u00e9claration des cas de pharmacovigilance. 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