{"id":57871,"date":"2025-04-21T17:58:29","date_gmt":"2025-04-21T15:58:29","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/developpement-preclinique\/"},"modified":"2025-04-21T17:58:29","modified_gmt":"2025-04-21T15:58:29","slug":"developpement-preclinique","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/developpement-preclinique\/","title":{"rendered":"D\u00e9veloppement pr\u00e9clinique"},"content":{"rendered":"<p><strong>Ma\u00eetrisez le d\u00e9veloppement pr\u00e9clinique des m\u00e9dicaments : des \u00e9tudes conformes aux BPL aux donn\u00e9es pr\u00eates pour l\u2019IND<\/strong><\/p>\n<p>Plus de 90 % des candidats-m\u00e9dicaments qui entrent en phase de tests pr\u00e9cliniques n\u2019atteignent jamais le d\u00e9p\u00f4t d\u2019une IND. Ce parcours d\u2019apprentissage en ligne certifi\u00e9 en d\u00e9veloppement pr\u00e9clinique, \u00e9labor\u00e9 sous la direction experte de la Dre Patricia Kay, apporte aux scientifiques, responsables de laboratoire et professionnels des affaires r\u00e9glementaires le cadre des BPL, les outils de gestion des risques et la m\u00e9thodologie de s\u00e9curit\u00e9 non clinique n\u00e9cessaires pour concevoir des \u00e9tudes capables de r\u00e9sister \u00e0 l\u2019examen de la FDA et de l\u2019EMA et de fournir les preuves exig\u00e9es par une IND. <\/p>\n<p>&nbsp;<\/p>\n<p><strong>D\u00e9tail du cours :<\/strong><\/p>\n<ul>\n<li><strong>Introduction aux Bonnes Pratiques de Laboratoire (BPL) :<\/strong> Comprenez le fondement r\u00e9glementaire des \u00e9tudes non cliniques et comment les principes des BPL prot\u00e8gent l\u2019int\u00e9grit\u00e9 des donn\u00e9es, de la conception de l\u2019\u00e9tude au rapport final.<\/li>\n<li><strong>21 CFR Part 58 : BPL pour les laboratoires non cliniques :<\/strong> Ma\u00eetrisez les exigences r\u00e9glementaires am\u00e9ricaines pour les \u00e9tudes non cliniques, y compris les responsabilit\u00e9s du directeur d\u2019\u00e9tude, les SOP et la pr\u00e9paration aux inspections pr\u00e9-IND.<\/li>\n<li><strong>Syst\u00e8mes de gestion de laboratoire, ISO\/CEI 17025:2017 :<\/strong> Appliquez les normes de comp\u00e9tence internationales pour que vos activit\u00e9s d\u2019essai et d\u2019\u00e9talonnage r\u00e9pondent aux attentes d\u2019accr\u00e9ditation et de r\u00e9glementation.<\/li>\n<li><strong>Formation certifi\u00e9e OSHA sur la s\u00e9curit\u00e9 en laboratoire :<\/strong> D\u00e9veloppez la culture de s\u00e9curit\u00e9 et les connaissances en conformit\u00e9 requises pour exploiter un laboratoire non clinique s\u00fbr et conforme.<\/li>\n<li><strong>Gestion des risques li\u00e9s \u00e0 la qualit\u00e9 :<\/strong> Utilisez des outils align\u00e9s sur l\u2019ICH Q9 pour identifier, \u00e9valuer et att\u00e9nuer proactivement les risques dans l\u2019ensemble des activit\u00e9s de d\u00e9veloppement pr\u00e9clinique.<\/li>\n<li><strong>Dossier d\u2019\u00e9valuation de la s\u00e9curit\u00e9 pour la premi\u00e8re administration \u00e0 l\u2019homme (FIHSA) :<\/strong> Apprenez comment les donn\u00e9es de s\u00e9curit\u00e9 pr\u00e9cliniques sont compil\u00e9es et \u00e9valu\u00e9es pour justifier le passage des \u00e9tudes animales aux premiers essais cliniques chez l\u2019homme.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Pourquoi choisir ce parcours d\u2019apprentissage ?<\/strong><\/p>\n<ul>\n<li><strong>Programme dirig\u00e9 par des experts :<\/strong> D\u00e9velopp\u00e9 par la Dre Patricia Kay, dirigeante senior en sciences de la vie avec plus de 20 ans d\u2019exp\u00e9rience en d\u00e9veloppement clinique et pr\u00e9clinique, strat\u00e9gie r\u00e9glementaire et gestion de la qualit\u00e9 dans les programmes cardiovasculaires, d\u2019immunologie et de maladies infectieuses.<\/li>\n<li><strong>Couverture compl\u00e8te :<\/strong> Des fondamentaux des BPL \u00e0 la gestion des risques ICH Q9 et \u00e0 la pr\u00e9paration du dossier FIHSA, toutes les dimensions critiques de la conformit\u00e9 pr\u00e9clinique en un seul parcours.<\/li>\n<li><strong>Apprentissage flexible :<\/strong> Enti\u00e8rement en ligne et \u00e0 votre rythme. \u00c9tudiez selon votre emploi du temps et revoyez n\u2019importe quel module \u00e0 mesure que les directives de la FDA et de l\u2019ICH \u00e9voluent. <\/li>\n<li><strong>Certification reconnue :<\/strong> Obtenez un certificat accr\u00e9dit\u00e9 CPD\/CEU et conforme au 21 CFR Part 11, que vous pouvez partager sur LinkedIn pour d\u00e9montrer vos comp\u00e9tences pr\u00e9cliniques aux employeurs, sponsors et r\u00e9gulateurs.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Ce que vous serez capable de faire<\/strong><\/p>\n<ul>\n<li>Concevoir et documenter des \u00e9tudes non cliniques conformes aux BPL qui r\u00e9pondent aux exigences de la FDA 21 CFR Part 58.<\/li>\n<li>Pr\u00e9parer et d\u00e9fendre un dossier d\u2019\u00e9valuation de la s\u00e9curit\u00e9 pour la premi\u00e8re administration \u00e0 l\u2019homme avant une soumission d\u2019IND.<\/li>\n<li>Mettre en \u0153uvre la gestion des risques ICH Q9 dans l\u2019ensemble des op\u00e9rations de laboratoire.<\/li>\n<li>Soutenir la pr\u00e9paration de votre organisation aux inspections pr\u00e9-IND et de pr\u00e9-approbation.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>\u00c0 qui s\u2019adresse cette formation ?<\/strong><\/p>\n<p>Que vous soyez chercheur scientifique, responsable de laboratoire, directeur d\u2019\u00e9tude, professionnel des affaires r\u00e9glementaires ou sp\u00e9cialiste de l\u2019assurance qualit\u00e9, cette formation en d\u00e9veloppement pr\u00e9clinique a \u00e9t\u00e9 con\u00e7ue pour vous. Elle est tout aussi pr\u00e9cieuse pour les \u00e9quipes pharmaceutiques et biotechnologiques int\u00e9grant du personnel dans des environnements r\u00e9gis par les BPL ou renfor\u00e7ant leurs capacit\u00e9s pr\u00e9cliniques internes avant un premier d\u00e9p\u00f4t d\u2019IND. <\/p>\n<p>&nbsp;<\/p>\n<p><strong>B\u00e2tissez le socle pr\u00e9clinique indispensable \u00e0 tout programme de d\u00e9veloppement de m\u00e9dicament<\/strong><\/p>\n<p>GxP Training propose des formations certifi\u00e9es et reconnues par les employeurs aux professionnels des sciences de la vie du monde entier. \u00c0 une \u00e9poque o\u00f9 la FDA renforce son contr\u00f4le sur les dossiers de donn\u00e9es non cliniques, la comp\u00e9tence pr\u00e9clinique n\u2019est plus facultative. C\u2019est le fondement de tout programme de d\u00e9veloppement r\u00e9ussi. Inscrivez-vous d\u00e8s aujourd\u2019hui et franchissez une nouvelle \u00e9tape dans votre carri\u00e8re pr\u00e9clinique.   <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ma\u00eetrisez le d\u00e9veloppement pr\u00e9clinique des m\u00e9dicaments : des \u00e9tudes conformes aux BPL aux donn\u00e9es pr\u00eates pour l\u2019IND Plus de 90 % des candidats-m\u00e9dicaments qui entrent en phase de tests pr\u00e9cliniques n\u2019atteignent jamais le d\u00e9p\u00f4t d\u2019une IND. Ce parcours d\u2019apprentissage en ligne certifi\u00e9 en d\u00e9veloppement pr\u00e9clinique, \u00e9labor\u00e9 sous la direction experte de la Dre Patricia Kay, [&hellip;]<\/p>\n","protected":false},"featured_media":55863,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[284],"product_tag":[],"class_list":{"0":"post-57871","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":[57302,57773,57766,57808,57118,57296],"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 certifiant pour le d\u00e9veloppement pr\u00e9clinique - GxP Training : Certified Online Courses for Life Sciences<\/title>\n<meta name=\"description\" content=\"Formation en ligne certifi\u00e9e en d\u00e9veloppement pr\u00e9clinique. 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