{"id":27306,"date":"2020-02-26T11:04:29","date_gmt":"2020-02-26T10:04:29","guid":{"rendered":"https:\/\/kymos.com\/news\/bioanalisi-armonizzazione-esperienza-e-buone-pratiche\/"},"modified":"2020-02-26T11:04:29","modified_gmt":"2020-02-26T10:04:29","slug":"bioanalisi-armonizzazione-esperienza-e-buone-pratiche","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/bioanalisi-armonizzazione-esperienza-e-buone-pratiche\/","title":{"rendered":"Bioanalisi: armonizzazione, esperienza e buone pratiche"},"content":{"rendered":"

L’importanza dell’armonizzazione ICH M10<\/strong><\/span><\/h3>\n
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La nostra responsabile di Bioanalisi, Digna Tost, vanta 30 anni di esperienza nel settore delle soluzioni di bioanalisi. In questo articolo, commenta l’attuale armonizzazione ICH delle linee guida globali in ambito bioanalitico e il valore aggiunto di un team solido e del rispetto delle buone pratiche. <\/span><\/p>\n

Sono stati pubblicati i verbali M10 del Consiglio Internazionale per l’Armonizzazione (ICH) per migliorare la coerenza dei dati bioanalitici e affrontare le divergenze tra gli standard in diverse parti del mondo. Con la crescente internazionalizzazione della bioanalisi, \u00e8 importante coordinare le linee guida normative. Digna Tost fornisce qui consigli su come conformarsi a livello globale: <\/span><\/p>\n

“Nella bioanalisi la regolamentazione globale \u00e8 un inizio, ma le buone pratiche fanno la differenza”, afferma. <\/em><\/span><\/p>\n

Sia il monitoraggio della conformit\u00e0 normativa da parte delle autorit\u00e0 di ciascun Paese che la sua esecuzione da parte delle CRO sono problematiche a causa delle differenze tra i Paesi. Le agenzie di regolamentazione hanno respinto progetti a causa di inesattezze in pi\u00f9 occasioni, quindi \u00e8 importante scegliere l’azienda giusta quando si valuta la bioanalisi. <\/span><\/p>\n

Le nostre soluzioni di bioanalisi<\/strong><\/span>
\nIn KYMOS, Digna e il suo consolidato reparto di bioanalisi collaborano con i clienti per fornire bioanalisi di livello mondiale a livello esperto. Grazie alla sua esperienza multidisciplinare, il team di Digna comprende l’intero processo di produzione farmaceutica, dalle fasi precliniche e cliniche all’approvazione finale e agli studi post-marketing. <\/span><\/p>\n

Si prevede che la linea guida ICH M10<\/a> sar\u00e0 adottata a novembre 2020 per fornire linee guida chiare per l’esecuzione delle analisi bioanalitiche. Per migliorare la qualit\u00e0, la coerenza e l’affidabilit\u00e0 dei dati bioanalitici o il supporto normativo, Digna consiglia di consultare i verbali dell’ultima assemblea ICH o di contattare Kymos al numero +34 935 481 848. <\/span><\/p>\n

Clicca qui per saperne di pi\u00f9 sulle nostre soluzioni di bioanalisi per piccole molecole<\/a> , prodotti biologici e biosimilari.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

L’importanza dell’armonizzazione ICH M10 La nostra responsabile di Bioanalisi, Digna […]<\/p>\n","protected":false},"author":6,"featured_media":27307,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[253],"tags":[],"class_list":["post-27306","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi"],"acf":[],"yoast_head":"\nBioanalisi - Armonizzazione, Esperienza e Buone Pratiche<\/title>\n<meta name=\"description\" content=\"Scopri di pi\u00f9 sull'armonizzazione in arrivo nel campo della bioanalisi con le soluzioni e le buone pratiche ICH M10 e 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\/it\/news\/bioanalisi-armonizzazione-esperienza-e-buone-pratiche\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bioanalisi - 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