{"id":7782,"date":"2024-05-28T11:04:52","date_gmt":"2024-05-28T16:04:52","guid":{"rendered":"https:\/\/fifarma.org\/?p=7782"},"modified":"2024-05-28T11:04:57","modified_gmt":"2024-05-28T16:04:57","slug":"nuevo-ensayo-de-reliance","status":"publish","type":"post","link":"https:\/\/fifarma.org\/pt\/nuevo-ensayo-de-reliance\/","title":{"rendered":"Construindo Confian\u00e7a e Efici\u00eancia: O Novo Ensaio de Reliance em Aprova\u00e7\u00f5es Farmac\u00eauticas"},"content":{"rendered":"<p>Bem, vamos falar sobre Reliance com este novo estudo que veio \u00e0 luz. Basicamente, a Organiza\u00e7\u00e3o Mundial da Sa\u00fade (OMS) quer garantir que as pessoas em todo o mundo possam acessar produtos m\u00e9dicos seguros e eficazes sem demoras. Eles pensam (e na FIFARMA concordamos) que uma maneira de fazer isso \u00e9 fazendo com que diferentes regi\u00f5es confiem nas avalia\u00e7\u00f5es que outros pa\u00edses fazem sobre esses produtos.&nbsp;<\/p>\n\n\n\n<p>Em vez de cada pa\u00eds realizar sua pr\u00f3pria revis\u00e3o minuciosa, eles incentivam a confian\u00e7a na avalia\u00e7\u00e3o feita por uma autoridade reguladora confi\u00e1vel, como a Ag\u00eancia Europeia de Medicamentos (EMA).<\/p>\n\n\n\n<p>Neste momento, isso n\u00e3o est\u00e1 acontecendo tanto quanto gostar\u00edamos, especialmente para certos tipos de aprova\u00e7\u00f5es. Por isso, est\u00e3o testando algo novo com uma empresa biotecnol\u00f3gica multinacional. Esta empresa est\u00e1 testando um sistema no qual muitos pa\u00edses concordam em usar um processo de aprova\u00e7\u00e3o mais curto baseado no que uma autoridade de confian\u00e7a, como a EMA, j\u00e1 aprovou.<\/p>\n\n\n\n<p>Por exemplo, uma empresa biotecnol\u00f3gica multinacional fez uma grande mudan\u00e7a na maneira como fabrica um medicamento espec\u00edfico. Em vez de cada pa\u00eds revisar essa mudan\u00e7a separadamente, eles a enviaram para 48 pa\u00edses ao mesmo tempo, todos concordando em participar deste teste. Sup\u00f5e-se que esses pa\u00edses estudem o que a EMA j\u00e1 revisou e decidam se tamb\u00e9m concordam, dentro de um prazo estabelecido.<\/p>\n\n\n\n<p>Para garantir que todos estejam na mesma p\u00e1gina, a empresa compartilhou todas as informa\u00e7\u00f5es da EMA com esses pa\u00edses. Eles tamb\u00e9m estabeleceram um sistema onde qualquer pergunta que os pa\u00edses tenham durante seu processo de revis\u00e3o \u00e9 respondida e compartilhada com todos os envolvidos. Dessa forma, todos sabem o que est\u00e1 acontecendo e podem tomar decis\u00f5es mais rapidamente.<\/p>\n\n\n\n<p>O principal objetivo deste teste \u00e9 tornar o processo de aprova\u00e7\u00e3o de mudan\u00e7as em medicamentos mais r\u00e1pido e menos complicado globalmente. A empresa espera reduzir o tempo que leva para a aprova\u00e7\u00e3o de cerca de 2,5 anos para apenas 6,5 meses. Eles tamb\u00e9m querem gerar confian\u00e7a com as pessoas importantes envolvidas e facilitar que diferentes pa\u00edses cheguem a um acordo sobre o que \u00e9 necess\u00e1rio para a aprova\u00e7\u00e3o, sem que cada pa\u00eds tenha seus pr\u00f3prios requisitos espec\u00edficos.<\/p>\n\n\n\n<p>\u00c9 uma estrat\u00e9gia inovadora que agiliza o processo de aprova\u00e7\u00e3o de medicamentos ao basear-se em decis\u00f5es regulat\u00f3rias tomadas em outras regi\u00f5es do mundo, facilitando assim um acesso mais r\u00e1pido a tratamentos vitais.<\/p>\n\n\n\n<p>Este \u00e9 um passo significativo para garantir um fornecimento cont\u00ednuo de medicamentos essenciais e promover a converg\u00eancia regulat\u00f3ria global como exemplo para nossa regi\u00e3o! Espero que o tema tenha despertado interesse e ajude voc\u00ea a entender por que a Reliance nos envolve a todos.<\/p>\n\n    <div class=\"xs_social_share_widget xs_share_url after_content \t\tmain_content  wslu-style-1 wslu-share-box-shaped wslu-fill-colored wslu-none wslu-share-horizontal wslu-theme-font-no wslu-main_content\">\n\n\t\t\n        <ul>\n\t\t\t        <\/ul>\n    <\/div>","protected":false},"excerpt":{"rendered":"<p>Bueno, hablemos de Reliance con este nuevo estudio que sali\u00f3 a la luz. B\u00e1sicamente, la Organizaci\u00f3n Mundial de la Salud (OMS) quiere asegurarse de que las personas en todo el mundo puedan acceder a productos m\u00e9dicos seguros y efectivos sin demoras. Piensan (y en FIFARMA estamos de acuerdo) que una manera de hacerlo es logrando [&hellip;]<\/p>","protected":false},"author":24,"featured_media":7764,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"enableOnePageScrollInPage":false,"onePageScrollCss":"","onePageScrollSpeed":1000,"onePageScrollAnimation":"easeInOutQuad","onePageScrollShowDotNavigation":true,"onePageScrollNavigation":"scaleUp","onePageScrollNavigationPosition":"right","onePageScrollNavigationHorizontal":[],"onePageScrollNavigationVertical":[],"onePageScrollNavigationSpacing":[],"onePageScrollNavigationColor":"#00ff0d","onePageScrollNavigationColorHover":"#00ff0d","onePageScrollNavigationColorActive":"#00ff0d","onePageScrollNavigationIcon":[],"onePageScrollNavigationWidth":[],"onePageScrollNavigationWidthHover":[],"onePageScrollNavigationWidthActive":[],"onePageScrollNavigationHeight":[],"onePageScrollNavigationHeightHover":[],"onePageScrollNavigationHeightActive":[],"onePageScrollNavigationBorder":[],"onePageScrollNavigationBorderHover":[],"onePageScrollNavigationBorderActive":[],"onePageScrollNavigationBorderRadius":[],"onePageScrollNavigationBorderRadiusHover":[],"onePageScrollNavigationBorderRadiusActive":[],"onePageScrollNavigationTooltipTypography":[],"onePageScrollNavigationTooltipColor":"#ffffff","onePageScrollNavigationTooltipColorHover":"","onePageScrollNavigationTooltipBgColor":"#00ff0d","onePageScrollNavigationTooltipBgColorHover":"","onePageScrollNavigationTooltipPadding":[],"onePageScrollNavigationTooltipPaddingHover":[],"onePageScrollNavigationTooltipBorderRadius":[],"onePageScrollNavigationTooltipBorderRadiusHover":[],"pageSettingsCustomCss":"","footnotes":""},"categories":[149],"tags":[159,160,146],"class_list":["post-7782","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reliance","tag-ensayo","tag-farmaceuticas","tag-reliance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.7 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Construyendo Confianza y Eficiencia: El Nuevo Ensayo de Reliance en Aprobaciones Farmac\u00e9uticas - FIFARMA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fifarma.org\/pt\/nuevo-ensayo-de-reliance\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Construyendo Confianza y Eficiencia: El Nuevo Ensayo de Reliance en Aprobaciones Farmac\u00e9uticas\" \/>\n<meta property=\"og:description\" content=\"Bueno, hablemos de Reliance con este nuevo estudio que sali\u00f3 a la luz. 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