{"id":7852,"date":"2024-12-17T17:18:41","date_gmt":"2024-12-17T17:18:41","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7852"},"modified":"2024-12-17T17:28:39","modified_gmt":"2024-12-17T17:28:39","slug":"ema-lanca-consulta-publica-sobre-o-uso-de-dados","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/ema-lanca-consulta-publica-sobre-o-uso-de-dados\/","title":{"rendered":"EMA lan\u00e7a consulta p\u00fablica sobre o uso de dados do mundo real na regula\u00e7\u00e3o de medicamentos"},"content":{"rendered":"<p>A Ag\u00eancia Europeia de Medicamentos <strong>(EMA) <\/strong>lan\u00e7a consulta p\u00fablica sobre uso de dados do mundo real na regula\u00e7\u00e3o de medicamentos do Quadro de Qualidade dos Dados para a Regula\u00e7\u00e3o de Medicamentos.<\/p>\n<p>Esta consulta visa a proposta de um cap\u00edtulo para o <strong>Quadro de Qualidade dos Dados<\/strong> na <strong>regula\u00e7\u00e3o de medicamentos<\/strong> da Uni\u00e3o Europeia.<\/p>\n<p>O cap\u00edtulo foi desenvolvido com a colabora\u00e7\u00e3o do <strong>Methodology Working Party<\/strong> e do <strong>CHMP<\/strong>. Al\u00e9m disso, tamb\u00e9m contou com o apoio do <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/work-programme\/workplan-2023-2025-hma-ema-joint-big-data-steering-group_en.pdf\">Big Data Steering Group<\/a> (BDSG)<\/strong>, uma iniciativa organizada pela <strong>EMA<\/strong> e do <strong>HMA.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Participe na consulta p\u00fablica at\u00e9 31 de janeiro de 2025<\/strong><\/h3>\n<p>Considerando que o objetivo da consulta \u00e9 fortalecer a regula\u00e7\u00e3o do setor farmac\u00eautico na Uni\u00e3o Europeia, a consulta p\u00fablica estar\u00e1 aberta at\u00e9 31 de janeiro de 2025 por meio do site da EMA.<\/p>\n<p>Adicionalmente, a consulta est\u00e1 destinada a profissionais da pesquisa, regula\u00e7\u00e3o de medicamentos e especialistas em ci\u00eancia de dados.<\/p>\n<p>As contribui\u00e7\u00f5es podem ser enviadas atrav\u00e9s de um <a href=\"https:\/\/ec.europa.eu\/eusurvey\/runner\/b55d7909-9b3f-f454-9711-152ef78e7913\"><strong>question\u00e1rio online<\/strong><\/a>.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Principais temas da consulta p\u00fablica sobre dados do mundo real (RWD)<\/strong><\/h3>\n<p>Os principais temas abordados na <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/about-us\/how-we-work\/big-data\/data-quality-framework-medicines-regulation#public-consultation-on-real-world-data-quality-71852\">consulta p\u00fablica<\/a><\/strong> incluem:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Em primeiro lugar,<strong> recomenda\u00e7\u00f5es para a avalia\u00e7\u00e3o da qualidade no uso de dados<\/strong> (RWD) por meio de m\u00e9tricas espec\u00edficas;<\/li>\n<li>Em segundo lugar, <strong>caracteriza\u00e7\u00e3o de sistemas e processos<\/strong> para recolha de dados confi\u00e1veis;<\/li>\n<li>Por fim, determina\u00e7\u00e3o da <strong>relev\u00e2ncia dos dados para quest\u00f5es de investiga\u00e7\u00e3o e desenvolvimento de medicamentos<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><strong>O que \u00e9 o Quadro de Qualidade dos Dados para a Regula\u00e7\u00e3o de Medicamentos?<\/strong><\/h3>\n<p>O <strong>Quadro de Qualidade dos Dados para a Regula\u00e7\u00e3o de Medicamentos<\/strong> \u00e9 um documento que apoia as <strong>decis\u00f5es regulat\u00f3rias com base na qualidade dos dados<\/strong> para <strong>avaliar a rela\u00e7\u00e3o benef\u00edcio-risco<\/strong>.<\/p>\n<p>Adicionalmente, estabelece crit\u00e9rios claros para garantir consist\u00eancia e padroniza\u00e7\u00e3o na avalia\u00e7\u00e3o do uso de dados cient\u00edficos e dados do mundo real.<\/p>\n<p>Mas, quais s\u00e3o os seus <strong>principais objetivos<\/strong>?<\/p>\n<ol>\n<li><strong>Identificar<\/strong> e <strong>desenvolver<\/strong> procedimentos de avalia\u00e7\u00e3o da qualidade dos dados;<\/li>\n<li><strong>Apoiar empresas<\/strong> na sele\u00e7\u00e3o de fontes de <strong>dados confi\u00e1veis<\/strong>;<\/li>\n<li><strong>Garantir a confian\u00e7a<\/strong> dos <strong>pacientes<\/strong> e <strong>profissionais de sa\u00fade<\/strong> nas <strong>decis\u00f5es regulat\u00f3rias<\/strong>.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h3><strong>Por que a consulta p\u00fablica \u00e9 importante para a regula\u00e7\u00e3o de medicamentos?<\/strong><\/h3>\n<p>A <strong>consulta p\u00fablica<\/strong> sobre o uso de dados na regula\u00e7\u00e3o de medicamentos \u00e9 essencial para melhorar a avalia\u00e7\u00e3o de medicamentos e as pol\u00edticas de regula\u00e7\u00e3o farmac\u00eautica na Uni\u00e3o Europeia. Desta forma, esta consulta contribuir\u00e1 para o futuro da regula\u00e7\u00e3o de medicamentos, ajudando a garantir qualidade e transpar\u00eancia nos processos regulat\u00f3rios.<\/p>\n<p>Al\u00e9m disso, os servi\u00e7os de regulamenta\u00e7\u00e3o da ELS garantem a m\u00e1xima qualidade e transpar\u00eancia para todos os clientes com os quais trabalhamos.<\/p>\n<p>Consequentemente, entregamos resultados com agilidade e conformidade com os novos padr\u00f5es, mantendo-nos sempre atualizados.<\/p>\n<p style=\"text-align: left;\">Se precisar de mais informa\u00e7\u00f5es sobre <strong>quest\u00f5es regulat\u00f3rias<\/strong> ou <strong>medicamentos<\/strong>, a <strong>ELS<\/strong> poder\u00e1 ajudar.<\/p>\n<p style=\"text-align: left;\"><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">Por favor entre em contato com o seu <a href=\"https:\/\/els-solutions.com\/onde-estamos\/\" target=\"_blank\" rel=\"noopener\">consultor local da ELS<\/a> <\/span><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">ou atrav\u00e9s do email: <strong>info@elssolutions.pt<\/strong><\/span><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA abre consulta p\u00fablica sobre uso de dados na regula\u00e7\u00e3o de medicamentos do Quadro de Qualidade dos Dados para a Regula\u00e7\u00e3o de Medicamentos.<\/p>\n","protected":false},"author":9,"featured_media":7868,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[88,67,68,87,53,65,60,69],"tags":[89,90,70,64],"class_list":["post-7852","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-consulta-publica","category-els","category-els-group","category-ema","category-geral","category-medicamentos","category-noticias","category-questoes-regulatorias","tag-consulta","tag-ema","tag-medicamentos","tag-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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