{"id":27314,"date":"2020-02-26T11:04:29","date_gmt":"2020-02-26T10:04:29","guid":{"rendered":"https:\/\/kymos.com\/news\/bioanalyse-harmonisation-experience-et-bonnes-pratiques\/"},"modified":"2020-02-26T11:04:29","modified_gmt":"2020-02-26T10:04:29","slug":"bioanalyse-harmonisation-experience-et-bonnes-pratiques","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/bioanalyse-harmonisation-experience-et-bonnes-pratiques\/","title":{"rendered":"Bioanalyse : Harmonisation, exp\u00e9rience et bonnes pratiques"},"content":{"rendered":"

L’importance de l’harmonisation ICH M10<\/strong><\/span><\/h3>\n
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Notre responsable de la bioanalyse, Digna Tost, poss\u00e8de 30 ans d’exp\u00e9rience dans le domaine des solutions de bioanalyse. Elle nous parle ici de l’harmonisation actuelle des lignes directrices internationales en bioanalyse par l’ICH et de l’importance d’une \u00e9quipe solide et du respect des bonnes pratiques. <\/span><\/p>\n

Le compte rendu M10 du Conseil international d’harmonisation (ICH) a \u00e9t\u00e9 publi\u00e9 afin d’am\u00e9liorer la coh\u00e9rence des donn\u00e9es bioanalytiques et d’harmoniser les normes en vigueur dans le monde. Face \u00e0 l’internationalisation croissante de la bioanalyse, il est essentiel de coordonner les directives r\u00e9glementaires. Digna Tost propose ici des conseils pour se conformer aux exigences \u00e0 l’\u00e9chelle mondiale : <\/span><\/p>\n

\u00ab En bioanalyse, la r\u00e9glementation mondiale est un d\u00e9but, mais ce sont les bonnes pratiques qui font la diff\u00e9rence \u00bb, affirme-t-elle. <\/em><\/span><\/p>\n

Le contr\u00f4le de la conformit\u00e9 r\u00e9glementaire par les autorit\u00e9s de chaque pays et sa mise en \u0153uvre par les CRO sont complexes en raison des diff\u00e9rences entre les pays. Les agences r\u00e9glementaires ont rejet\u00e9 des projets \u00e0 plusieurs reprises pour cause d’inexactitudes ; il est donc essentiel de choisir la bonne entreprise pour les bioanalyses. <\/span><\/p>\n

Nos solutions de bioanalyse<\/strong><\/span>
\nChez KYMOS, Digna et son d\u00e9partement de bioanalyse chevronn\u00e9 collaborent \u00e9troitement avec les clients pour fournir des analyses de pointe r\u00e9alis\u00e9es par des experts. Forte d’une exp\u00e9rience multidisciplinaire, l’\u00e9quipe de Digna ma\u00eetrise l’ensemble du processus de fabrication pharmaceutique, des phases pr\u00e9cliniques et cliniques jusqu’\u00e0 l’autorisation de mise sur le march\u00e9 et les \u00e9tudes post-commercialisation. <\/span><\/p>\n

La directive ICH M10<\/a> devrait \u00eatre adopt\u00e9e en novembre 2020 afin de fournir des lignes directrices claires pour la r\u00e9alisation d’analyses bioanalytiques. Si vous souhaitez am\u00e9liorer la qualit\u00e9, la coh\u00e9rence et la fiabilit\u00e9 de vos donn\u00e9es bioanalytiques ou de votre dossier r\u00e9glementaire, Digna vous recommande de consulter le compte rendu de la derni\u00e8re r\u00e9union de l’ICH ou de contacter Kymos au +34 935 481 848. <\/span><\/p>\n

Cliquez ici pour en savoir plus sur nos solutions de bioanalyse pour les petites mol\u00e9cules<\/a> , les produits biologiques et les biosimilaires.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

L’importance de l’harmonisation ICH M10 Notre responsable de la bioanalyse, […]<\/p>\n","protected":false},"author":6,"featured_media":27316,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[257],"tags":[],"class_list":["post-27314","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse"],"acf":[],"yoast_head":"\nBioanalyse \u2013 Harmonisation, exp\u00e9rience et bonnes pratiques<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez plus en d\u00e9tail l'harmonisation \u00e0 venir dans le domaine de la bioanalyse avec les solutions et les bonnes pratiques ICH M10 et Kymos.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/fr\/news\/bioanalyse-harmonisation-experience-et-bonnes-pratiques\/\" \/>\n<meta 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