{"id":57136,"date":"2022-11-14T16:05:09","date_gmt":"2022-11-14T15:05:09","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/affaires-reglementaires-pharmaceutiques\/"},"modified":"2022-11-14T16:05:09","modified_gmt":"2022-11-14T15:05:09","slug":"affaires-reglementaires-pharmaceutiques","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/affaires-reglementaires-pharmaceutiques\/","title":{"rendered":"Affaires R\u00e9glementaires Pharmaceutiques"},"content":{"rendered":"<p>Les Affaires R\u00e9glementaires (AR) constituent un d\u00e9partement au sein des organisations pharmaceutiques qui obtient l&rsquo;approbation de commercialisation de nouveaux produits pharmaceutiques aupr\u00e8s des autorit\u00e9s r\u00e9glementaires comp\u00e9tentes. Elles veillent \u00e9galement \u00e0 ce que cette approbation soit maintenue aussi longtemps que l&rsquo;entreprise souhaite conserver le produit approuv\u00e9 sur le march\u00e9. Ensemble, les autorit\u00e9s r\u00e9glementaires et la division des affaires r\u00e9glementaires \u0153uvrent vers un objectif commun : garantir que les patients b\u00e9n\u00e9ficient de traitements m\u00e9dicaux nouveaux et am\u00e9lior\u00e9s tout en d\u00e9montrant le plus haut niveau de s\u00e9curit\u00e9 et d&rsquo;efficacit\u00e9.  <\/p>\n<p>Dans cette formation en ligne, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience en ligne interactive. Ce contenu a \u00e9t\u00e9 \u00e9labor\u00e9 par une \u00e9quipe d&rsquo;experts en Affaires R\u00e9glementaires qualifi\u00e9s de la Northeastern University, Boston, dirig\u00e9e par un membre senior capable d&rsquo;articuler th\u00e9orie et pratique. <\/p>\n<h3><\/h3>\n<h3><\/h3>\n<h3>Programme :<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introduction<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Que sont les <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/affaires-reglementaires\/\">affaires r\u00e9glementaires<\/a> ?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : L&rsquo;importance des affaires r\u00e9glementaires<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Comprendre le processus de d\u00e9veloppement de m\u00e9dicaments<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Que sont les autorit\u00e9s r\u00e9glementaires nationales et internationales ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : Processus r\u00e9glementaire d&rsquo;approbation et d&rsquo;enregistrement des m\u00e9dicaments<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Affaires R\u00e9glementaires aux \u00c9tats-Unis<\/li>\n<li>Demandes d&rsquo;approbation r\u00e9glementaire aux \u00c9tats-Unis<\/li>\n<li>Demande de nouveau m\u00e9dicament<\/li>\n<li>Affaires R\u00e9glementaires dans l&rsquo;UE<\/li>\n<li>Processus d&rsquo;approbation r\u00e9glementaire dans l&rsquo;UE<\/li>\n<li>Demande de soumission de dossier<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les Affaires R\u00e9glementaires (AR) constituent un d\u00e9partement au sein des organisations pharmaceutiques qui obtient l&rsquo;approbation de commercialisation de nouveaux produits pharmaceutiques aupr\u00e8s des autorit\u00e9s r\u00e9glementaires comp\u00e9tentes. Elles veillent \u00e9galement \u00e0 ce que cette approbation soit maintenue aussi longtemps que l&rsquo;entreprise souhaite conserver le produit approuv\u00e9 sur le march\u00e9. Ensemble, les autorit\u00e9s r\u00e9glementaires et la division [&hellip;]<\/p>\n","protected":false},"featured_media":42971,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,263,258],"product_tag":[],"class_list":{"0":"post-57136","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-organisme-de-recherche-sous-contrat-cro","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>Affaires R\u00e9glementaires Pharmaceutiques - Formation en Ligne Certifiante<\/title>\n<meta name=\"description\" content=\"Formation en ligne sur les Affaires R\u00e9glementaires Pharmaceutiques pour les professionnels et d\u00e9butants des sciences de la vie. 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