{"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":"investigacion-sobre-seguridad-de-medicamentos-de-la-fda-de-taiwan","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/taiwan-fda-drug-safety-research\/","title":{"rendered":"La FDA de Taiw\u00e1n public\u00f3 las directrices para la implementaci\u00f3n..."},"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>La evidencia del mundo real es la \u00faltima tendencia de aplicaci\u00f3n cl\u00ednica internacional, que se puede utilizar para mejorar el dise\u00f1o de\u00a0<span class=\"highlighted-text\">ensayos cl\u00ednicos<\/span>, y como ayuda para la eficacia o seguridad de los medicamentos antes y despu\u00e9s de su comercializaci\u00f3n. La mayor\u00eda de los pa\u00edses se centran en desarrollar la aplicaci\u00f3n de la evidencia del mundo real y formular normas pertinentes.<\/p>\n<p>Con referencia a las tendencias de gesti\u00f3n internacionales y las condiciones nacionales, se formulan las \u201cDirectrices para la implementaci\u00f3n de la investigaci\u00f3n sobre seguridad epidemiol\u00f3gica de medicamentos utilizando datos electr\u00f3nicos de atenci\u00f3n m\u00e9dica\u201d para el desarrollo de medicamentos a nivel nacional.<\/p>\n<p>A continuaci\u00f3n se presenta un resumen de la estructura de la gu\u00eda:<\/p>\n<ul>\n<li>Introducci\u00f3n\n<ul>\n<li>T\u00edtulo y detalles del resumen de la investigaci\u00f3n<\/li>\n<li>Antecedentes de investigaci\u00f3n<\/li>\n<li>Consideraci\u00f3n de los m\u00e9todos de investigaci\u00f3n<\/li>\n<li>Competencia profesional y certificaci\u00f3n del equipo de investigaci\u00f3n<\/li>\n<li>Interpretaci\u00f3n de los resultados de la investigaci\u00f3n<\/li>\n<\/ul>\n<\/li>\n<li>Fuentes de informaci\u00f3n\n<ul>\n<li>Adecuaci\u00f3n de las fuentes de datos a la cuesti\u00f3n de seguridad que se va a estudiar<\/li>\n<li>La integridad de la entrada del paciente en la base de datos y la informaci\u00f3n de atenci\u00f3n.<\/li>\n<li>Fuentes nacionales de datos y sistemas de atenci\u00f3n<\/li>\n<li>Selecci\u00f3n del grupo objetivo de la investigaci\u00f3n<\/li>\n<li>Garant\u00eda de calidad y control de calidad<\/li>\n<li>Problemas con el marco temporal de la investigaci\u00f3n y el tiempo de demora<\/li>\n<\/ul>\n<\/li>\n<li>Dise\u00f1o de investigaci\u00f3n\n<ul>\n<li>Consideraci\u00f3n general del dise\u00f1o de la investigaci\u00f3n<\/li>\n<li>Definici\u00f3n de exposici\u00f3n a drogas y confirmaci\u00f3n de la exposici\u00f3n<\/li>\n<li>Definici\u00f3n de resultados de seguridad y confirmaci\u00f3n de la ocurrencia de resultados<\/li>\n<\/ul>\n<\/li>\n<li>M\u00e9todo anal\u00edtico\n<ul>\n<li>Plan de an\u00e1lisis predefinido<\/li>\n<li>M\u00e9todos de investigaci\u00f3n y an\u00e1lisis<\/li>\n<li>Uso de m\u00e9todos estad\u00edsticos espec\u00edficos<\/li>\n<li>An\u00e1lisis de sensibilidad<\/li>\n<li>Vincular o agrupar diferentes fuentes de informaci\u00f3n<\/li>\n<li>Evaluaci\u00f3n y procesamiento de datos faltantes e ininterpretables<\/li>\n<li>Garant\u00eda de calidad y control de calidad<\/li>\n<li>Procedimientos para garantizar la exactitud del proceso de procesamiento y an\u00e1lisis de datos<\/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\/es\/contacto\/\">Contacte con RegASK para saber m\u00e1s sobre los cambios regulatorios en la 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\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/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>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1321359761\">\n\n\t<div id=\"col-742032066\" 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\/es\/estudios-de-caso\/recursos-casos-de-estudio-farmacia-biotecnologia\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria farmac\u00e9utica y biotecnol\u00f3gica<\/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>La evidencia del mundo real es la \u00faltima tendencia internacional en aplicaciones cl\u00ednicas, que puede utilizarse para mejorar el dise\u00f1o de ensayos cl\u00ednicos y como apoyo para la eficacia o seguridad de los medicamentos antes y despu\u00e9s de su comercializaci\u00f3n. La mayor\u00eda de los pa\u00edses se centran en desarrollar la aplicaci\u00f3n de la evidencia del mundo real y en formular normas pertinentes. Con referencia a la normativa internacional\u2026<\/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 v27.6 (Yoast SEO v27.6) - 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. 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Mant\u00e9ngase a la vanguardia.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/investigacion-sobre-seguridad-de-medicamentos-de-la-fda-de-taiwan\/","og_locale":"es_ES","og_type":"article","og_title":"Taiwan FDA published Guidelines for the Implementation of Drug Epidemiological Safety Research Using Electronic Health Care Data","og_description":"Taiwan FDA strengthens drug safety with guidelines for epidemiological research using electronic health data. 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