{"id":57986,"date":"2025-01-06T09:31:31","date_gmt":"2025-01-06T09:31:31","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/cmc-chimie-fabrication-et-controles\/"},"modified":"2025-01-06T09:31:31","modified_gmt":"2025-01-06T08:31:31","slug":"cmc-chimie-fabrication-et-controles","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/cmc-chimie-fabrication-et-controles\/","title":{"rendered":"CMC : Chimie, Fabrication et Contr\u00f4les"},"content":{"rendered":"<p data-pm-slice=\"1 1 []\">Ma\u00eetrisez les fondamentaux de la <a href=\"https:\/\/www.fda.gov\/animal-veterinary\/guidance-industry\/chemistry-manufacturing-and-controls-cmc-guidances-industry-gfis-and-questions-and-answers-qas\">Chimie, Fabrication et Contr\u00f4les<\/a> (CMC) gr\u00e2ce \u00e0 notre cours de formation certifi\u00e9.<\/p>\n<div class=\"relative flex-col gap-1 md:gap-3\">\n<div class=\"flex max-w-full flex-col grow\">\n<div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"f2bc1d34-6d77-413a-a47e-729be77ead34\" data-message-model-slug=\"gpt-4o\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose dark:prose-invert w-full break-words light\">\n<p data-start=\"0\" data-end=\"440\" data-is-last-node=\"\" data-is-only-node=\"\">Les informations relatives \u00e0 la chimie, \u00e0 la fabrication et aux contr\u00f4les (CMC) des m\u00e9dicaments sont une partie essentielle d&rsquo;un dossier utilis\u00e9 pour soutenir les \u00e9tudes cliniques et les demandes de mise sur le march\u00e9. Ces informations doivent \u00eatre mises \u00e0 jour \u00e0 mesure que de nouvelles donn\u00e9es deviennent disponibles au cours du cycle de vie du m\u00e9dicament. La CMC est exig\u00e9e par les autorit\u00e9s r\u00e9glementaires, y compris la FDA, l&rsquo;EMA et d&rsquo;autres organismes de r\u00e9glementation mondiaux. Elle doit \u00eatre soumise dans le cadre des d\u00e9p\u00f4ts r\u00e9glementaires tels que les IND, les NDA et les BLA. Une documentation CMC appropri\u00e9e est essentielle pour la conformit\u00e9 r\u00e9glementaire, les approbations et la r\u00e9ussite des audits.    <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>Notre cours certifi\u00e9 couvre les phases cl\u00e9s, du d\u00e9veloppement de produits et des essais cliniques \u00e0 l&rsquo;approbation de mise sur le march\u00e9 et \u00e0 la gestion post-approbation. Il fournit les connaissances et les outils essentiels pour g\u00e9rer efficacement les exigences CMC, r\u00e9duire les risques de conformit\u00e9 lors des audits et assurer le succ\u00e8s des approbations de produits. <\/p>\n<p>&nbsp;<\/p>\n<p><b>Qui devrait s&rsquo;inscrire ?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ce cours est id\u00e9al pour les professionnels des <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/specialiste-des-affaires-reglementaires\/\">affaires r\u00e9glementaires<\/a>, de l&rsquo;<a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/assurance-qualite\/\">assurance qualit\u00e9<\/a>, du d\u00e9veloppement pharmaceutique, de la fabrication et de la gestion de projet qui sont responsables d&rsquo;assurer la conformit\u00e9 des produits et les soumissions r\u00e9glementaires.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Sujets abord\u00e9s dans le cours :<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Exigences CMC cl\u00e9s pour les essais cliniques et les demandes de mise sur le march\u00e9.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Gestion efficace des changements CMC post-approbation.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Conseils pour la pr\u00e9paration et la maintenance de la documentation CMC essentielle.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Meilleures pratiques pour assurer la conformit\u00e9 avec les agences de r\u00e9glementation.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Int\u00e9gration de la CMC dans les syst\u00e8mes de qualit\u00e9 et de fabrication.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Chaque session int\u00e8gre des exemples concrets et des \u00e9valuations pratiques pour garantir une exp\u00e9rience d&rsquo;apprentissage riche et pratique. Apr\u00e8s avoir r\u00e9ussi le cours, les participants recevront un certificat de formation CMC, enti\u00e8rement reconnu lors des audits r\u00e9glementaires. <\/p>\n<p>&nbsp;<\/p>\n<h3><b>Programme :<\/b><\/h3>\n<p><b>Vid\u00e9o d&rsquo;introduction<\/b><\/p>\n<p><b>Le\u00e7on 1 : Informations g\u00e9n\u00e9rales sur la CMC<\/b><\/p>\n<ul>\n<li>Chimie<\/li>\n<li><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/introduction-aux-bonnes-pratiques-de-fabrication-bpf\/\">Fabrication<\/a><\/li>\n<li>Contr\u00f4les<\/li>\n<li>Documentation et structure de la CMC (Document Technique Commun (CTD))<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>Le\u00e7on 2 : Directives sp\u00e9cifiques \u00e0 la CMC<\/b><\/p>\n<ul>\n<li>Directives du <a href=\"https:\/\/gxp-training.com\/fr\/bpc\/ich-gcp-e6r3-avez-vous-besoin-dune-nouvelle-formation-dequipe\/\">Conseil International d&rsquo;Harmonisation (ICH)<\/a> pour les soumissions CMC<\/li>\n<li>Mise en \u0153uvre des directives ICH dans la documentation CMC<\/li>\n<li>Documents d&rsquo;orientation cl\u00e9s de la FDA pertinents pour la CMC<\/li>\n<li>Directives de l&rsquo;Agence Europ\u00e9enne des M\u00e9dicaments<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>Le\u00e7on 3 : CMC pour les essais cliniques<\/b><\/p>\n<ul>\n<li>Qu&rsquo;est-ce qu&rsquo;une demande d&rsquo;autorisation de nouveau m\u00e9dicament exp\u00e9rimental (IND) ?<\/li>\n<li>Exigences CMC pour les essais cliniques de phase I, II et III<\/li>\n<li>Amendements CMC pendant les essais cliniques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>Le\u00e7on 4 : CMC pour les demandes de mise sur le march\u00e9<\/b><\/p>\n<div class=\"noOutline\" data-block-id=\"cm06ts7cy0206206ygfm265cd\" data-change-path=\"[\"lessons\",{\"id\":\"oKh8McWx5tJ4AI5jU9v18miDlNKgyGAU\"},\"items\",{\"id\":\"cm06ts7cy0206206ygfm265cd\"}]\">\n<div>\n<div class=\"block-statement block-statement--b block-statement--b-custom-width-med block-statement--b-divider-padding-sm block-statement--b-divider-size-sm block-wrapper bg bg--range-light bg--type-light\">\n<div class=\"block-statement__wrap\">\n<div class=\"block-statement__container\">\n<div class=\"block-statement__row\">\n<div>\n<div class=\"\">\n<div class=\"block-statement__col\">\n<div class=\"block-statement__quote\">\n<div>\n<div class=\" brand--linkColor\">\n<div class=\"fr-view rise-tiptap\">\n<ul>\n<li>Aper\u00e7u des soumissions <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/soumettre-une-demande-de-nouveau-medicament-nda-aux-etats-unis\/\">NDA<\/a> et BLA<\/li>\n<li>Informations CMC pour l&rsquo;approbation de mise sur le march\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><b>Le\u00e7on 5 : CMC post-approbation<\/b><\/p>\n<ul>\n<li>Exigences r\u00e9glementaires pour les changements post-approbation<\/li>\n<li>Suppl\u00e9ments et amendements CMC<\/li>\n<li>Pr\u00e9paration et soumission des suppl\u00e9ments CMC<\/li>\n<li>Gestion des risques et strat\u00e9gies de contr\u00f4le<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>Conclusion<\/b><\/p>\n<p><b>\u00c9valuation<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ma\u00eetrisez les fondamentaux de la Chimie, Fabrication et Contr\u00f4les (CMC) gr\u00e2ce \u00e0 notre cours de formation certifi\u00e9. Les informations relatives \u00e0 la chimie, \u00e0 la fabrication et aux contr\u00f4les (CMC) des m\u00e9dicaments sont une partie essentielle d&rsquo;un dossier utilis\u00e9 pour soutenir les \u00e9tudes cliniques et les demandes de mise sur le march\u00e9. Ces informations doivent [&hellip;]<\/p>\n","protected":false},"featured_media":51292,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,254,258],"product_tag":[],"class_list":{"0":"post-57986","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-bpf-bonnes-pratiques-de-fabrication","8":"product_cat-pharmaceutique","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"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 CMC Pharma<\/title>\n<meta name=\"description\" content=\"D\u00e9butez votre formation en Chimie, Fabrication et Contr\u00f4les avec des exemples concrets et obtenez un certificat reconnu mondialement. 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