{"id":58072,"date":"2025-04-22T09:00:45","date_gmt":"2025-04-22T07:00:45","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/soumission-reglementaire-nda\/"},"modified":"2025-04-22T09:00:45","modified_gmt":"2025-04-22T07:00:45","slug":"soumission-reglementaire-nda","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/","title":{"rendered":"Soumission r\u00e9glementaire (NDA)"},"content":{"rendered":"<p><strong>Formation soumission NDA : ma\u00eetrisez le processus d&rsquo;approbation de m\u00e9dicaments par la FDA, du CMC \u00e0 l&rsquo;approbation<\/strong><\/p>\n<p>Une seule d\u00e9ficience dans un dossier NDA peut co\u00fbter \u00e0 un promoteur 10 \u00e0 24 mois et des dizaines de millions de dollars. Ce parcours de formation en ligne certifi\u00e9 pour les soumissions NDA aux \u00c9tats-Unis, d\u00e9velopp\u00e9 sous la direction experte du Dr Patricia Kay, offre aux professionnels des affaires r\u00e9glementaires, aux scientifiques CMC et aux responsables de soumissions le cadre, les normes de documentation et la pr\u00e9paration aux inspections n\u00e9cessaires pour constituer et d\u00e9fendre une demande de nouveau m\u00e9dicament qui r\u00e9pond aux exigences de la FDA \u00e0 chaque \u00e9tape. <\/p>\n<p>&nbsp;<\/p>\n<p><strong>Parcours de formation :<\/strong><\/p>\n<ul>\n<li><strong>Soumettre une demande de nouveau m\u00e9dicament (NDA) :<\/strong> parcourez l&rsquo;ensemble du processus NDA, de la structure eCTD et du contenu des modules aux d\u00e9lais d&rsquo;examen de la FDA, aux lettres de r\u00e9ponse compl\u00e8te et aux voies d&rsquo;approbation.<\/li>\n<li><strong>CMC : chimie, fabrication et contr\u00f4les :<\/strong> d\u00e9veloppez votre expertise dans la section CMC, couvrant la substance m\u00e9dicamenteuse, le produit m\u00e9dicamenteux, les m\u00e9thodes analytiques et la documentation des processus exig\u00e9es par la FDA.<\/li>\n<li><strong>Affaires r\u00e9glementaires pharmaceutiques :<\/strong> d\u00e9veloppez les fondements de la strat\u00e9gie r\u00e9glementaire qui fa\u00e7onne la planification des soumissions et la gestion du cycle de vie.<\/li>\n<li><strong>Bonnes pratiques de documentation (GDocP) :<\/strong> appliquez les principes ALCOA+ afin que chaque enregistrement de votre dossier NDA r\u00e9ponde aux normes d&rsquo;int\u00e9grit\u00e9 des donn\u00e9es de la FDA.<\/li>\n<li><strong>Int\u00e9grit\u00e9 des donn\u00e9es pharmaceutiques : ALCOA et ALCOA+ :<\/strong> comprenez les exigences d&rsquo;int\u00e9grit\u00e9 des donn\u00e9es que les inspecteurs de la FDA examinent lors de l&rsquo;examen de la NDA et des inspections pr\u00e9alables \u00e0 l&rsquo;approbation.<\/li>\n<li><strong>Introduction au 21 CFR Part 11 de la FDA :<\/strong> assurez-vous que vos enregistrements \u00e9lectroniques, signatures et pistes d&rsquo;audit r\u00e9pondent aux exigences du 21 CFR Part 11 qui s&rsquo;appliquent \u00e0 toutes les donn\u00e9es NDA g\u00e9r\u00e9es \u00e9lectroniquement.<\/li>\n<li><strong>Inspections de conformit\u00e9 r\u00e9glementaire et audits externes :<\/strong> pr\u00e9parez votre organisation aux inspections pr\u00e9alables \u00e0 l&rsquo;approbation de la FDA, y compris les proc\u00e9dures, les observations courantes et la mani\u00e8re de d\u00e9montrer une conformit\u00e9 robuste.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Pourquoi choisir ce parcours de formation ?<\/strong><\/p>\n<ul>\n<li><strong>Programme dirig\u00e9 par des experts :<\/strong> d\u00e9velopp\u00e9 par le Dr Patricia Kay, responsable senior dans les sciences de la vie avec plus de 20 ans d&rsquo;exp\u00e9rience en strat\u00e9gie r\u00e9glementaire, d\u00e9veloppement clinique et gestion de la conformit\u00e9.<\/li>\n<li><strong>Couverture compl\u00e8te :<\/strong> de la structure eCTD et de la documentation CMC \u00e0 l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es, la conformit\u00e9 Part 11 et la pr\u00e9paration aux inspections, toutes les dimensions critiques d&rsquo;une NDA r\u00e9ussie en un seul parcours.<\/li>\n<li><strong>Apprentissage flexible :<\/strong> enti\u00e8rement \u00e0 votre rythme et en ligne. D\u00e9veloppez votre expertise NDA selon votre emploi du temps. <\/li>\n<li><strong>Certification reconnue :<\/strong> obtenez un certificat accr\u00e9dit\u00e9 CPD\/CEU, conforme au 21 CFR Part 11, validant votre comp\u00e9tence en soumission NDA aupr\u00e8s des employeurs, promoteurs et organismes r\u00e9glementaires.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Ce que vous serez capable de faire<\/strong><\/p>\n<ul>\n<li>Structurer une soumission eCTD qui r\u00e9pond aux normes techniques de la FDA.<\/li>\n<li>R\u00e9diger et examiner les sections CMC pour r\u00e9sister \u00e0 l&rsquo;examen de la FDA.<\/li>\n<li>Appliquer les exigences ALCOA+ et 21 CFR Part 11 \u00e0 l&rsquo;ensemble de la documentation de soumission.<\/li>\n<li>Pr\u00e9parer votre site \u00e0 une inspection pr\u00e9alable \u00e0 l&rsquo;approbation de la FDA.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>\u00c0 qui s&rsquo;adresse cette formation ?<\/strong><\/p>\n<p>Que vous soyez sp\u00e9cialiste des affaires r\u00e9glementaires, scientifique CMC, responsable des op\u00e9rations cliniques ou professionnel de la qualit\u00e9 pr\u00e9parant votre premi\u00e8re NDA, ou approfondissant une expertise existante en soumission, ce parcours a \u00e9t\u00e9 con\u00e7u pour vous. Il est tout aussi pr\u00e9cieux pour les \u00e9quipes pharmaceutiques d\u00e9veloppant des capacit\u00e9s internes en affaires r\u00e9glementaires ou se pr\u00e9parant aux inspections pr\u00e9alables \u00e0 l&rsquo;approbation de la FDA. <\/p>\n<p>&nbsp;<\/p>\n<p><strong>Transformez la complexit\u00e9 r\u00e9glementaire en avantage concurrentiel<\/strong><\/p>\n<p>GxP Training propose des formations certifi\u00e9es et reconnues par les employeurs aux professionnels des sciences de la vie dans le monde entier. Dans un environnement FDA de plus en plus scrut\u00e9, l&rsquo;expertise en soumission NDA fait partie des comp\u00e9tences les plus valoris\u00e9es dans l&rsquo;industrie pharmaceutique. Inscrivez-vous d\u00e8s aujourd&rsquo;hui et d\u00e9veloppez les comp\u00e9tences qui permettent de mettre les m\u00e9dicaments sur le march\u00e9.  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Formation soumission NDA : ma\u00eetrisez le processus d&rsquo;approbation de m\u00e9dicaments par la FDA, du CMC \u00e0 l&rsquo;approbation Une seule d\u00e9ficience dans un dossier NDA peut co\u00fbter \u00e0 un promoteur 10 \u00e0 24 mois et des dizaines de millions de dollars. Ce parcours de formation en ligne certifi\u00e9 pour les soumissions NDA aux \u00c9tats-Unis, d\u00e9velopp\u00e9 sous [&hellip;]<\/p>\n","protected":false},"featured_media":55866,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[284],"product_tag":[],"class_list":{"0":"post-58072","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-parcours-dapprentissage","8":"first","9":"instock","10":"taxable","11":"shipping-taxable","12":"purchasable","13":"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":[57969,57986,57136,57738,57758,57160,57380],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Parcours de formation certifi\u00e9 pour la soumission et l&#039;approbation de NDA - GxP Training : Certified Online Courses for Life Sciences<\/title>\n<meta name=\"description\" content=\"Formation en ligne certifi\u00e9e sur la soumission de NDA. Ma\u00eetrisez l&#039;eCTD, le CMC, ALCOA+, le 21 CFR Part 11 et la pr\u00e9paration aux inspections FDA. Certificats reconnus pour l&#039;approbation de m\u00e9dicaments.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Parcours de formation certifi\u00e9 pour la soumission et l&#039;approbation de NDA - GxP Training : Certified Online Courses for Life Sciences\" \/>\n<meta property=\"og:description\" content=\"Formation en ligne certifi\u00e9e sur la soumission de NDA. Ma\u00eetrisez l&#039;eCTD, le CMC, ALCOA+, le 21 CFR Part 11 et la pr\u00e9paration aux inspections FDA. Certificats reconnus pour l&#039;approbation de m\u00e9dicaments.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/\" \/>\n<meta property=\"og:site_name\" content=\"GxP Training : Certified Online Courses for Life Sciences\" \/>\n<meta property=\"og:image\" content=\"https:\/\/gxp-training.com\/wp-content\/uploads\/2026\/04\/nda-regulatory-submission-learning-path-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"900\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/\",\"name\":\"Parcours de formation certifi\u00e9 pour la soumission et l'approbation de NDA - GxP Training : Certified Online Courses for Life Sciences\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/nda-regulatory-submission-learning-path-1.jpg\",\"datePublished\":\"2025-04-22T07:00:45+00:00\",\"description\":\"Formation en ligne certifi\u00e9e sur la soumission de NDA. Ma\u00eetrisez l'eCTD, le CMC, ALCOA+, le 21 CFR Part 11 et la pr\u00e9paration aux inspections FDA. Certificats reconnus pour l'approbation de m\u00e9dicaments.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/#primaryimage\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/nda-regulatory-submission-learning-path-1.jpg\",\"contentUrl\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/nda-regulatory-submission-learning-path-1.jpg\",\"width\":900,\"height\":627},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/soumission-reglementaire-nda\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/page-daccueil\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Produits\",\"item\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/shop\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Soumission r\u00e9glementaire (NDA)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/\",\"name\":\"GxP Training : Certified Online Courses for Life Sciences\",\"description\":\"Online Trainings and Certified Courses in Regulatory Compliance for Pharmaceutical Experts\",\"publisher\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#organization\",\"name\":\"GXP Training\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2022\\\/05\\\/logo-resize.png\",\"contentUrl\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2022\\\/05\\\/logo-resize.png\",\"width\":350,\"height\":100,\"caption\":\"GXP Training\"},\"image\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Parcours de formation certifi\u00e9 pour la soumission et l'approbation de NDA - GxP Training : Certified Online Courses for Life Sciences","description":"Formation en ligne certifi\u00e9e sur la soumission de NDA. Ma\u00eetrisez l'eCTD, le CMC, ALCOA+, le 21 CFR Part 11 et la pr\u00e9paration aux inspections FDA. Certificats reconnus pour l'approbation de m\u00e9dicaments.","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:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/","og_locale":"fr_FR","og_type":"article","og_title":"Parcours de formation certifi\u00e9 pour la soumission et l'approbation de NDA - GxP Training : Certified Online Courses for Life Sciences","og_description":"Formation en ligne certifi\u00e9e sur la soumission de NDA. Ma\u00eetrisez l'eCTD, le CMC, ALCOA+, le 21 CFR Part 11 et la pr\u00e9paration aux inspections FDA. Certificats reconnus pour l'approbation de m\u00e9dicaments.","og_url":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/","og_site_name":"GxP Training : Certified Online Courses for Life Sciences","og_image":[{"width":900,"height":627,"url":"https:\/\/gxp-training.com\/wp-content\/uploads\/2026\/04\/nda-regulatory-submission-learning-path-1.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/","url":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/","name":"Parcours de formation certifi\u00e9 pour la soumission et l'approbation de NDA - GxP Training : Certified Online Courses for Life Sciences","isPartOf":{"@id":"https:\/\/gxp-training.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/#primaryimage"},"image":{"@id":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/#primaryimage"},"thumbnailUrl":"https:\/\/gxp-training.com\/wp-content\/uploads\/2026\/04\/nda-regulatory-submission-learning-path-1.jpg","datePublished":"2025-04-22T07:00:45+00:00","description":"Formation en ligne certifi\u00e9e sur la soumission de NDA. Ma\u00eetrisez l'eCTD, le CMC, ALCOA+, le 21 CFR Part 11 et la pr\u00e9paration aux inspections FDA. Certificats reconnus pour l'approbation de m\u00e9dicaments.","breadcrumb":{"@id":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/#primaryimage","url":"https:\/\/gxp-training.com\/wp-content\/uploads\/2026\/04\/nda-regulatory-submission-learning-path-1.jpg","contentUrl":"https:\/\/gxp-training.com\/wp-content\/uploads\/2026\/04\/nda-regulatory-submission-learning-path-1.jpg","width":900,"height":627},{"@type":"BreadcrumbList","@id":"https:\/\/gxp-training.com\/fr\/online-course\/soumission-reglementaire-nda\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/gxp-training.com\/fr\/page-daccueil\/"},{"@type":"ListItem","position":2,"name":"Produits","item":"https:\/\/gxp-training.com\/fr\/shop\/"},{"@type":"ListItem","position":3,"name":"Soumission r\u00e9glementaire (NDA)"}]},{"@type":"WebSite","@id":"https:\/\/gxp-training.com\/fr\/#website","url":"https:\/\/gxp-training.com\/fr\/","name":"GxP Training : Certified Online Courses for Life Sciences","description":"Online Trainings and Certified Courses in Regulatory Compliance for Pharmaceutical Experts","publisher":{"@id":"https:\/\/gxp-training.com\/fr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/gxp-training.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/gxp-training.com\/fr\/#organization","name":"GXP Training","url":"https:\/\/gxp-training.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/gxp-training.com\/fr\/#\/schema\/logo\/image\/","url":"https:\/\/gxp-training.com\/wp-content\/uploads\/2022\/05\/logo-resize.png","contentUrl":"https:\/\/gxp-training.com\/wp-content\/uploads\/2022\/05\/logo-resize.png","width":350,"height":100,"caption":"GXP Training"},"image":{"@id":"https:\/\/gxp-training.com\/fr\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product\/58072","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/media\/55866"}],"wp:attachment":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/media?parent=58072"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product_brand?post=58072"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product_cat?post=58072"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product_tag?post=58072"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}