{"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":"arzneimittelsicherheitsforschung-der-taiwanesischen-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/taiwan-fda-drug-safety-research\/","title":{"rendered":"Die taiwanesische FDA hat Leitlinien zur Umsetzung ver\u00f6ffentlicht \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>Real-World-Evidenz ist der neueste internationale Trend in der klinischen Anwendung, der zur Verbesserung des Designs von\u00a0<span class=\"highlighted-text\">klinische Studien<\/span>und als Hilfestellung zur Beurteilung der Wirksamkeit oder Sicherheit von Arzneimitteln vor und nach der Markteinf\u00fchrung. Die Mehrheit der L\u00e4nder konzentriert sich auf die Entwicklung der Anwendung von Real-World-Evidenz und die Formulierung relevanter Normen.<\/p>\n<p>Unter Ber\u00fccksichtigung internationaler Managementtrends und inl\u00e4ndischer Bedingungen wurden die \u201eRichtlinien f\u00fcr die Durchf\u00fchrung epidemiologischer Arzneimittelsicherheitsforschung unter Verwendung elektronischer Gesundheitsdaten\u201c als Orientierung f\u00fcr die inl\u00e4ndische Arzneimittelentwicklung formuliert.<\/p>\n<p>Nachfolgend finden Sie eine Zusammenfassung der Leitlinienstruktur:<\/p>\n<ul>\n<li>Einf\u00fchrung\n<ul>\n<li>Titel und Forschungszusammenfassung<\/li>\n<li>Forschungshintergrund<\/li>\n<li>Ber\u00fccksichtigung von Forschungsmethoden<\/li>\n<li>Fachliche Kompetenz und Zertifizierung des Forschungsteams<\/li>\n<li>Interpretation der Forschungsergebnisse<\/li>\n<\/ul>\n<\/li>\n<li>Informationsquellen\n<ul>\n<li>Eignung der Datenquellen f\u00fcr das zu untersuchende Sicherheitsproblem<\/li>\n<li>Die Integrit\u00e4t der Patienteneingabe in die Datenbank und Pflegeinformationen<\/li>\n<li>Nationale Quellen f\u00fcr Pflegesysteme und Daten<\/li>\n<li>Auswahl der Zielgruppe f\u00fcr die Forschung<\/li>\n<li>Qualit\u00e4tssicherung und Qualit\u00e4tskontrolle<\/li>\n<li>Probleme mit dem Forschungszeitrahmen und Verz\u00f6gerungen<\/li>\n<\/ul>\n<\/li>\n<li>Forschungsdesign\n<ul>\n<li>Gesamtbetrachtung des Forschungsdesigns<\/li>\n<li>Definition der Arzneimittelexposition und Best\u00e4tigung der Exposition<\/li>\n<li>Definition von Sicherheitsergebnissen und Best\u00e4tigung des Auftretens von Ergebnissen<\/li>\n<\/ul>\n<\/li>\n<li>Analytische Methode\n<ul>\n<li>Vordefinierter Analyseplan<\/li>\n<li>Forschungs- und Analysemethoden<\/li>\n<li>Einsatz spezifischer statistischer Methoden<\/li>\n<li>Sensitivit\u00e4tsanalyse<\/li>\n<li>Verkn\u00fcpfung oder B\u00fcndelung verschiedener Informationsquellen<\/li>\n<li>Auswertung und Aufbereitung fehlender und nicht interpretierbarer Daten<\/li>\n<li>Qualit\u00e4tssicherung und Qualit\u00e4tskontrolle<\/li>\n<li>Verfahren zur Gew\u00e4hrleistung der Genauigkeit des Datenverarbeitungs- und -analyseprozesses<\/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\/de\/kontakt\/\">Kontaktieren Sie RegASK, um mehr \u00fcber regulatorische \u00c4nderungen in der EU zu erfahren.\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\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1439464289\">\n\n\t<div id=\"col-1066790116\" 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\/de\/fallstudien\/ressourcen-fallstudien-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Pharma- und Biotech-Industrie<\/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 v27.8 (Yoast SEO v27.8) - 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\/de\/arzneimittelsicherheitsforschung-der-taiwanesischen-fda\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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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