{"id":4118,"date":"2023-02-07T14:43:54","date_gmt":"2023-02-07T06:43:54","guid":{"rendered":"https:\/\/regask.com\/?p=4118"},"modified":"2024-11-22T04:45:58","modified_gmt":"2024-11-21T20:45:58","slug":"recherche-sur-la-securite-des-medicaments-de-la-fda-a-taiwan","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/taiwan-fda-drug-safety-research\/","title":{"rendered":"La FDA de Ta\u00efwan a publi\u00e9 des lignes directrices pour la mise en \u0153uvre\u2026"},"content":{"rendered":"<div>\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<p>Les preuves du monde r\u00e9el constituent la derni\u00e8re tendance internationale en mati\u00e8re d\u2019application clinique, qui peut \u00eatre utilis\u00e9e pour am\u00e9liorer la conception de\u00a0<span class=\"highlighted-text\">essais cliniques<\/span>, et comme aide \u00e0 l&#039;efficacit\u00e9 ou \u00e0 la s\u00e9curit\u00e9 des m\u00e9dicaments avant et apr\u00e8s leur mise sur le march\u00e9. La majorit\u00e9 des pays se concentrent sur le d\u00e9veloppement de l&#039;application des donn\u00e9es probantes du monde r\u00e9el et sur la formulation de normes pertinentes.<\/p>\n<p>En r\u00e9f\u00e9rence aux tendances internationales en mati\u00e8re de gestion et aux conditions nationales, les \u00ab Lignes directrices pour la mise en \u0153uvre de la recherche sur la s\u00e9curit\u00e9 \u00e9pid\u00e9miologique des m\u00e9dicaments \u00e0 l&#039;aide de donn\u00e9es \u00e9lectroniques sur les soins de sant\u00e9 \u00bb sont formul\u00e9es pour le d\u00e9veloppement de m\u00e9dicaments nationaux \u00e0 suivre.<\/p>\n<p>Vous trouverez ci-dessous un r\u00e9sum\u00e9 de la structure des lignes directrices :<\/p>\n<ul>\n<li>Introduction\n<ul>\n<li>Titre et d\u00e9tails du r\u00e9sum\u00e9 de recherche<\/li>\n<li>Contexte de la recherche<\/li>\n<li>Prise en compte des m\u00e9thodes de recherche<\/li>\n<li>Comp\u00e9tence professionnelle et certification de l&#039;\u00e9quipe de recherche<\/li>\n<li>Interpr\u00e9tation des r\u00e9sultats de la recherche<\/li>\n<\/ul>\n<\/li>\n<li>Sources d&#039;information\n<ul>\n<li>Ad\u00e9quation des sources de donn\u00e9es au probl\u00e8me de s\u00e9curit\u00e9 \u00e0 \u00e9tudier<\/li>\n<li>L&#039;int\u00e9grit\u00e9 de l&#039;entr\u00e9e du patient dans la base de donn\u00e9es et des informations sur les soins<\/li>\n<li>Sources nationales des syst\u00e8mes de soins et des donn\u00e9es<\/li>\n<li>S\u00e9lection du groupe cible pour la recherche<\/li>\n<li>Assurance qualit\u00e9 et contr\u00f4le qualit\u00e9<\/li>\n<li>Probl\u00e8mes li\u00e9s au calendrier de recherche et aux d\u00e9lais de retard<\/li>\n<\/ul>\n<\/li>\n<li>Conception de la recherche\n<ul>\n<li>Prise en compte globale de la conception de la recherche<\/li>\n<li>D\u00e9finition de l&#039;exposition aux m\u00e9dicaments et confirmation de l&#039;exposition<\/li>\n<li>D\u00e9finition des r\u00e9sultats de s\u00e9curit\u00e9 et confirmation de l&#039;occurrence des r\u00e9sultats<\/li>\n<\/ul>\n<\/li>\n<li>M\u00e9thode analytique\n<ul>\n<li>Plan d&#039;analyse pr\u00e9d\u00e9fini<\/li>\n<li>M\u00e9thodes de recherche et d&#039;analyse<\/li>\n<li>Utilisation de m\u00e9thodes statistiques sp\u00e9cifiques<\/li>\n<li>Analyse de sensibilit\u00e9<\/li>\n<li>Relier ou mutualiser diff\u00e9rentes sources d&#039;information<\/li>\n<li>Evaluation et traitement des donn\u00e9es manquantes et ininterpr\u00e9tables<\/li>\n<li>Assurance qualit\u00e9 et contr\u00f4le qualit\u00e9<\/li>\n<li>Proc\u00e9dures visant \u00e0 garantir l&#039;exactitude du processus de traitement et d&#039;analyse des donn\u00e9es<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"css-18gzbx7\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-md-12\">\n<div class=\"jss1501\">\n<div class=\"jss1521\">\n<div class=\"jss409 jss434 summaryParagraph\">\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/fr\/contact-2\/\">Contactez RegASK pour en savoir plus sur les changements de r\u00e9glementation dans l&#039;UE.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov.tw\/TC\/newsContent.aspx?cid=3&#038;id=28356\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-246065319\">\n\n\t<div id=\"col-98059954\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lisez les \u00e9tudes de cas sur l&#039;industrie pharmaceutique et biotechnologique<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-xs-12\">\n<div class=\"jss1500\">\n<div class=\"jss409 jss417 dataText\"><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Real-world evidence is the latest international clinical application trend, which can be used to improve the design of\u00a0clinical trials, and as an aid to the efficacy or safety of drugs before and after marketing. The majority of the countries focus on developing the application of real-world evidence and formulating relevant norms. With reference to international&#8230;<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40],"class_list":["post-4118","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Taiwan FDA Boosts Drug Safety with New Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"Taiwan FDA strengthens drug safety with guidelines for epidemiological research using electronic health data. Stay ahead of the curve..\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/recherche-sur-la-securite-des-medicaments-de-la-fda-a-taiwan\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Taiwan FDA published Guidelines for the Implementation of Drug Epidemiological Safety Research Using Electronic Health Care Data\" \/>\n<meta property=\"og:description\" content=\"Taiwan FDA strengthens drug safety with guidelines for epidemiological research using electronic health data. 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