{"id":57296,"date":"2022-05-24T11:11:35","date_gmt":"2022-05-24T09:11:35","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/dossier-devaluation-de-la-securite-des-premieres-administrations-chez-lhomme-fihsa\/"},"modified":"2022-05-24T11:11:35","modified_gmt":"2022-05-24T09:11:35","slug":"dossier-devaluation-de-la-securite-des-premieres-administrations-chez-lhomme-fihsa","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/dossier-devaluation-de-la-securite-des-premieres-administrations-chez-lhomme-fihsa\/","title":{"rendered":"Dossier d&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme (FIHSA)"},"content":{"rendered":"<p>L&rsquo;importance de la s\u00e9curit\u00e9 concernant les produits pharmaceutiques et les dispositifs m\u00e9dicaux ne saurait \u00eatre surestim\u00e9e. Il est donc n\u00e9cessaire d&rsquo;\u00e9valuer la r\u00e9ponse du corps humain \u00e0 la pr\u00e9sence d&rsquo;un nouveau m\u00e9dicament ou dispositif. L&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme (FIHSA) est une partie vitale et fondamentale des essais cliniques, qui voit un m\u00e9dicament ou un dispositif exp\u00e9rimental passer de l&rsquo;utilisation chez l&rsquo;animal ou des simulations \u00e0 l&rsquo;utilisation chez l&rsquo;homme.  <\/p>\n<p>Ce cours vous emm\u00e8ne \u00e0 travers l&rsquo;\u00e9volution historique du concept de s\u00e9curit\u00e9, de la phase technologique \u00e0 la phase holistique qui prend en compte la technologie, les humains et l&rsquo;organisation. Vous serez initi\u00e9 aux m\u00e9thodes de d\u00e9termination des doses pour les \u00e9tudes FIHSA et au r\u00f4le des lignes directrices de la Conf\u00e9rence Internationale sur l&rsquo;Harmonisation (ICH) pour garantir que les risques sont r\u00e9duits au minimum. <\/p>\n<p>&nbsp;<\/p>\n<p>Dans ce cours, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience interactive en ligne. Ce mat\u00e9riel a \u00e9t\u00e9 \u00e9labor\u00e9 par une \u00e9quipe d&rsquo;experts en affaires r\u00e9glementaires, dipl\u00f4m\u00e9s de la Northeastern University, Boston, et pilot\u00e9 par un membre senior capable d&rsquo;articuler la th\u00e9orie et la pratique. <\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introduction<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Aspect historique de la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Premi\u00e8re phase de la s\u00e9curit\u00e9 \u2013 La technologie (<em>si la technologie est s\u00fbre, alors nous serons en s\u00e9curit\u00e9<\/em>)<\/li>\n<li>Deuxi\u00e8me phase de la s\u00e9curit\u00e9 \u2013 La phase humaine (si l&rsquo;humain est en s\u00e9curit\u00e9, alors nous serons en s\u00e9curit\u00e9)<\/li>\n<li>Troisi\u00e8me phase de la s\u00e9curit\u00e9 \u2013 La phase organisationnelle (si l&rsquo;organisation est s\u00fbre, alors nous serons en s\u00e9curit\u00e9)<\/li>\n<li>Quatri\u00e8me phase de la s\u00e9curit\u00e9 \u2013 L&rsquo;\u00e8re\/phase des syst\u00e8mes ou holistique<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Conception r\u00e9ussie des essais cliniques de s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Tests de s\u00e9curit\u00e9 pr\u00e9cliniques<\/li>\n<li>Surveillance de la s\u00e9curit\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : S\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme et processus de d\u00e9veloppement de m\u00e9dicaments<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Phases de la recherche clinique<\/li>\n<li>\u00c9tudes pr\u00e9cliniques<\/li>\n<li>Phase 0<\/li>\n<li>Phase I<\/li>\n<li>Phase II<\/li>\n<li>Phase III<\/li>\n<li>Phase IV<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : Estimation de la dose dans la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>L&rsquo;objectif du MSRD<\/li>\n<li>M\u00e9thodes d&rsquo;estimation du MRSD<\/li>\n<li>M\u00e9thode NOAEL<\/li>\n<li>L&rsquo;approche MABEL pour la s\u00e9lection de la dose<\/li>\n<li>M\u00e9thode de comparaison de m\u00e9dicaments similaires<\/li>\n<li>M\u00e9thode guid\u00e9e par la pharmacocin\u00e9tique<\/li>\n<li>Approche guid\u00e9e par la mod\u00e9lisation PK\/PD<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : \u00c9valuation des risques ; \u00c9valuation des risques pour la sant\u00e9 et la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Le processus d&rsquo;\u00e9valuation des risques<\/li>\n<li>Identification des dangers<\/li>\n<li>\u00c9valuation dose-r\u00e9ponse<\/li>\n<li>\u00c9valuation de l&rsquo;exposition<\/li>\n<li>Estimation et caract\u00e9risation des risques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : R\u00f4le de l&rsquo;ICH dans la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Objectifs de l&rsquo;ICH<\/li>\n<li>Membres de l&rsquo;ICH<\/li>\n<li>Structure de l&rsquo;ICH<\/li>\n<li>Comit\u00e9 directeur de l&rsquo;ICH<\/li>\n<li>Coordinateurs de l&rsquo;ICH<\/li>\n<li>Groupe de travail de l&rsquo;ICH<\/li>\n<li>Fonctionnement de l&rsquo;ICH<\/li>\n<li>Lignes directrices de s\u00e9curit\u00e9<\/li>\n<li>\u00c9tudes de canc\u00e9rog\u00e9nicit\u00e9 (S1A-S1C)<\/li>\n<li>S2 \u2013 G\u00e9notoxicit\u00e9<\/li>\n<li>S3A-S3B Toxicocin\u00e9tique et Pharmacocin\u00e9tique<\/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>D\u00e9finitions<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Quiz<\/strong><\/p>\n<p><strong> <\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L&rsquo;importance de la s\u00e9curit\u00e9 concernant les produits pharmaceutiques et les dispositifs m\u00e9dicaux ne saurait \u00eatre surestim\u00e9e. Il est donc n\u00e9cessaire d&rsquo;\u00e9valuer la r\u00e9ponse du corps humain \u00e0 la pr\u00e9sence d&rsquo;un nouveau m\u00e9dicament ou dispositif. L&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 des premi\u00e8res administrations chez l&rsquo;homme (FIHSA) est une partie vitale et fondamentale des essais cliniques, qui voit [&hellip;]<\/p>\n","protected":false},"featured_media":44653,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,274,256,263,258],"product_tag":[],"class_list":{"0":"post-57296","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-bpc-essais-cliniques","8":"product_cat-dispositifs-medicaux","9":"product_cat-organisme-de-recherche-sous-contrat-cro","10":"product_cat-pharmaceutique","12":"first","13":"instock","14":"taxable","15":"shipping-taxable","16":"purchasable","17":"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>S\u00e9curit\u00e9 dans les \u00e9tudes de premi\u00e8res administrations chez l&#039;homme \u2013 Cours en ligne et certificat<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez les diff\u00e9rentes \u00e9tapes du processus de d\u00e9couverte de m\u00e9dicaments et sa transition vers l&#039;utilisation chez l&#039;homme. 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