{"id":59719,"date":"2026-06-16T16:06:30","date_gmt":"2026-06-16T14:06:30","guid":{"rendered":"https:\/\/gxp-training.com\/?post_type=product&#038;p=59719"},"modified":"2026-06-22T09:08:21","modified_gmt":"2026-06-22T07:08:21","slug":"conformite-de-lia-dans-les-sciences-de-la-vie-reglement-de-lue-sur-lia-et-directives-de-la-fda","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/conformite-de-lia-dans-les-sciences-de-la-vie-reglement-de-lue-sur-lia-et-directives-de-la-fda\/","title":{"rendered":"Conformit\u00e9 de l\u2019IA dans les sciences de la vie &#8211; R\u00e8glement de l\u2019UE sur l\u2019IA et directives de la FDA"},"content":{"rendered":"<p>L\u2019intelligence artificielle trie d\u00e9j\u00e0 les \u00e9v\u00e9nements ind\u00e9sirables, s\u00e9lectionne les candidats aux essais cliniques et surveille les lignes de production dans tout le secteur des sciences de la vie. D\u00e9sormais, la r\u00e9glementation s\u2019est adapt\u00e9e : <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2024\/1689\/oj\">le r\u00e8glement de l\u2019UE sur l\u2019IA<\/a> et les directives croissantes de la FDA d\u00e9terminent si vos mod\u00e8les passent l\u2019inspection ou s\u2019ils mettent en p\u00e9ril vos soumissions, votre r\u00e9putation et vos patients. <\/p>\n<p>Ce cours transforme ces deux cadres en une m\u00e9thode claire et pr\u00eate pour l\u2019audit. Vos \u00e9quipes apprendront \u00e0 classer, valider, documenter et d\u00e9fendre chaque syst\u00e8me d\u2019IA d\u00e9ploy\u00e9. Du d\u00e9veloppement de m\u00e9dicaments \u00e0 la fabrication, en passant par la <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/bonnes-pratiques-de-pharmacovigilance-gvp\/\">pharmacovigilance<\/a> et la qualit\u00e9, rien n\u2019est laiss\u00e9 au hasard. Apr\u00e8s avoir r\u00e9ussi, vous recevrez un <strong>certificat tra\u00e7able accr\u00e9dit\u00e9 par des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 \u00e0 la documentation d\u2019audit et de conformit\u00e9.   <\/p>\n<p>&nbsp;<\/p>\n<p><strong>Ce que vous apprendrez<\/strong><\/p>\n<ul>\n<li>Cartographier le calendrier du r\u00e8glement de l\u2019UE sur l\u2019IA et l\u2019\u00e9cosyst\u00e8me des directives de la FDA<\/li>\n<li>Classer l\u2019IA selon le mod\u00e8le de risque \u00e0 quatre niveaux de l\u2019UE et le cadre du contexte d\u2019utilisation de la FDA<\/li>\n<li>Concevoir des programmes de litt\u00e9ratie en IA et \u00e9tendre la <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/assurance-logicielle-informatique-pour-les-sciences-de-la-vie\/\">validation CSV\/CSA<\/a> aux mod\u00e8les d\u2019IA<\/li>\n<li>D\u00e9fendre l\u2019<a href=\"https:\/\/gxp-training.com\/fr\/online-course\/integrite-des-donnees-pharmaceutiques-alcoa-et-alcoa\/\">int\u00e9grit\u00e9 des donn\u00e9es<\/a>, l\u2019explicabilit\u00e9, la surveillance humaine et la gouvernance de l\u2019IA g\u00e9n\u00e9rative<\/li>\n<li>\u00c9tablir une documentation prouvant la conformit\u00e9 de l\u2019IA pour les audits de la FDA et de l\u2019EMA<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>\u00c0 qui s\u2019adresse cette formation<\/strong><\/p>\n<ul>\n<li>Professionnels des affaires r\u00e9glementaires et de la conformit\u00e9<\/li>\n<li>Sp\u00e9cialistes de l\u2019assurance qualit\u00e9 et de la validation IT\/CSV<\/li>\n<li>\u00c9quipes des op\u00e9rations cliniques, de la pharmacovigilance et de la gestion des donn\u00e9es<\/li>\n<li>Auditeurs \u00e9valuant les programmes de gouvernance de l\u2019IA<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p><strong>Le\u00e7on : Une br\u00e8ve histoire de l\u2019IA dans les sciences de la vie<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : Pourquoi la conformit\u00e9 de l\u2019IA maintenant<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : Classification des risques de l\u2019IA<\/strong><\/p>\n<p><strong>Le\u00e7on 3 : Exigences en mati\u00e8re de litt\u00e9ratie en IA<\/strong><\/p>\n<p><strong>Le\u00e7on 4 : Validation et gestion du cycle de vie<\/strong><\/p>\n<p><strong>Le\u00e7on 5 : Int\u00e9grit\u00e9 des donn\u00e9es pour l\u2019IA<\/strong><\/p>\n<p><strong>Le\u00e7on 6 : Transparence et explicabilit\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 7 : L\u2019IA en pharmacovigilance<\/strong><\/p>\n<p><strong>Le\u00e7on 8 : L\u2019IA g\u00e9n\u00e9rative dans les flux de travail r\u00e9glement\u00e9s<\/strong><\/p>\n<p><strong>Le\u00e7on 9 : Feuille de route de mise en \u0153uvre<\/strong><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>\u00c9valuation finale<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019intelligence artificielle trie d\u00e9j\u00e0 les \u00e9v\u00e9nements ind\u00e9sirables, s\u00e9lectionne les candidats aux essais cliniques et surveille les lignes de production dans tout le secteur des sciences de la vie. D\u00e9sormais, la r\u00e9glementation s\u2019est adapt\u00e9e : le r\u00e8glement de l\u2019UE sur l\u2019IA et les directives croissantes de la FDA d\u00e9terminent si vos mod\u00e8les passent l\u2019inspection ou s\u2019ils [&hellip;]<\/p>\n","protected":false},"featured_media":59876,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,257,274,254,256,262,264,258,267],"product_tag":[],"class_list":{"0":"post-59719","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-assurance-qualite","8":"product_cat-bpc-essais-cliniques","9":"product_cat-bpf-bonnes-pratiques-de-fabrication","10":"product_cat-dispositifs-medicaux","11":"product_cat-hopitaux-et-etablissements-de-sante","12":"product_cat-transversal","13":"product_cat-pharmaceutique","14":"product_cat-pharmacovigilance-fr","16":"first","17":"instock","18":"virtual","19":"taxable","20":"purchasable","21":"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 v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Conformit\u00e9 de l\u2019IA dans les sciences de la vie - Formation certifiante pour professionnels<\/title>\n<meta name=\"description\" content=\"Formation certifiante en conformit\u00e9 de l\u2019IA pour les sciences de la vie, align\u00e9e sur le r\u00e8glement de l\u2019UE sur l\u2019IA et les directives de la FDA. 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