{"id":9458,"date":"2021-08-20T12:28:31","date_gmt":"2021-08-20T12:28:31","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9458"},"modified":"2023-03-10T09:43:35","modified_gmt":"2023-03-10T09:43:35","slug":"medical-device-risk-management-rmp-template-free","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/","title":{"rendered":"Plano de Gerenciamento de Riscos M\u00e9dicos (RMP) Modelo (GRATUITO)"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f2cdfe799d9\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f2cdfe799d9\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/#What_is_a_Risk_Management_Plan_RMP\" title=\"O que \u00e9 um Plano de Gerenciamento de Riscos (RMP)?\">O que \u00e9 um Plano de Gerenciamento de Riscos (RMP)?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/#Why_do_you_need_an_RMP_template\" title=\"Por que voc\u00ea precisa de um modelo RMP?\">Por que voc\u00ea precisa de um modelo RMP?<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Nare Simonyan<\/a>A Kolabtree, especialista em assuntos regulat\u00f3rios e ensaios cl\u00ednicos, fornece um <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-regulatory-dossier-and-what-does-it-contain\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Plano de Gerenciamento de Riscos<\/a> (RMP) que dispositivos m\u00e9dicos e empresas farmac\u00eauticas podem usar como ponto de refer\u00eancia para a apresenta\u00e7\u00e3o de seus produtos.<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_Risk_Management_Plan_RMP\"><\/span>O que \u00e9 um Plano de Gerenciamento de Riscos (RMP)?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Um Plano de Gerenciamento de Riscos ou RMP \u00e9 um documento que detalha as caracter\u00edsticas de seguran\u00e7a do medicamento, particularmente as conting\u00eancias em vigor para reduzir sua gravidade de risco entre os pacientes. O documento modelo RMP tamb\u00e9m exige que as empresas elaborem como estar\u00e3o envolvidas nos estudos em andamento para minimizar ou prevenir riscos e aumentar a seguran\u00e7a do medicamento.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_do_you_need_an_RMP_template\"><\/span>Por que voc\u00ea precisa de um modelo RMP?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>As empresas s\u00e3o obrigadas a apresentar um Plano de Gerenciamento de Riscos aos \u00f3rg\u00e3os m\u00e9dicos governantes, tais como a Ag\u00eancia Europ\u00e9ia de Medicamentos (EMA), enquanto solicitam a autoriza\u00e7\u00e3o de comercializa\u00e7\u00e3o. Al\u00e9m disso, qualquer autoridade nacional competente (NCA) \u00e9 eleg\u00edvel a solicitar um RMP para produtos m\u00e9dicos que s\u00e3o autorizados nacionalmente.<\/p>\n<p>Este modelo RMP gratuito atuar\u00e1 como um ponto de refer\u00eancia quando voc\u00ea precisar apresentar um Plano de Gerenciamento de Riscos para seu novo produto.<\/p>\n<div class=\"forminator-ui forminator-custom-form forminator-custom-form-10527 forminator-design--flat  forminator_ajax\" data-forminator-render=\"0\" data-form=\"forminator-module-10527\" data-uid=\"69f2cdfe71932\"><br\/><\/div><form\n\t\t\t\tid=\"forminator-module-10527\"\n\t\t\t\tclass=\"forminator-ui forminator-custom-form forminator-custom-form-10527 forminator-design--flat  forminator_ajax\"\n\t\t\t\tmethod=\"post\"\n\t\t\t\tdata-forminator-render=\"0\"\n\t\t\t\tdata-form-id=\"10527\"\n\t\t\t\t\n\t\t\t\tdata-design=\"flat\"\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tdata-grid=\"open\"\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tstyle=\"display: none;\"\n\t\t\t\t\n\t\t\t\tdata-uid=\"69f2cdfe71932\" action=\"\"\n\t\t\t><div class=\"forminator-response-message forminator-error\" aria-hidden=\"true\"><\/div><div class=\"forminator-row\"><div id=\"email-1\" class=\"forminator-col forminator-col-12\"><div class=\"forminator-field\"><label for=\"forminator-field-email-1_69f2cdfe71932\" class=\"forminator-label\">Email Address <span class=\"forminator-required\">*<\/span><\/label><input type=\"email\" name=\"email-1\" value=\"\" placeholder=\"\" id=\"forminator-field-email-1_69f2cdfe71932\" class=\"forminator-input forminator-email--field\" data-required=\"1\" aria-required=\"true\" \/><\/div><\/div><\/div><input type=\"hidden\" name=\"referer_url\" value=\"\" \/><div class=\"forminator-row forminator-row-last\"><div class=\"forminator-col\"><div class=\"forminator-field\"><button class=\"forminator-button forminator-button-submit\">Download the Free Template Here.<\/button><\/div><\/div><\/div><input type=\"hidden\" id=\"forminator_nonce\" name=\"forminator_nonce\" value=\"74690d92fd\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/blog\/pt\/wp-json\/wp\/v2\/posts\/9458\" \/><input type=\"hidden\" name=\"form_id\" value=\"10527\"><input type=\"hidden\" name=\"page_id\" value=\"9458\"><input type=\"hidden\" name=\"form_type\" value=\"default\"><input type=\"hidden\" name=\"current_url\" value=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/\"><input type=\"hidden\" name=\"render_id\" value=\"0\"><input type=\"hidden\" name=\"action\" value=\"forminator_submit_form_custom-forms\"><input type=\"hidden\" name=\"trp-form-language\" value=\"pt\"\/><\/form><p>Este modelo de RMP foi elaborado pela freelancer Kolabtree Nare Simonyan. a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">consultor regulador freelance<\/a> com um doutorado em ci\u00eancia farmac\u00eautica. Ela oferece consultoria especializada em uma ampla variedade de assuntos, tais como ensaios cl\u00ednicos, conformidade regulamentar, reda\u00e7\u00e3o cient\u00edfica e revis\u00e3o m\u00e9dica. Entre em contato diretamente com a Nare <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">aqui.<\/a><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Kolabtree<\/a> ajuda voc\u00ea a acessar uma rede global de especialistas cient\u00edficos e industriais diretamente. Nossos especialistas oferecem servi\u00e7os freelance em uma grande variedade de dom\u00ednios de nicho. Procurando contratar um especialista?<a href=\"https:\/\/www.kolabtree.com\/create-project?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> Postar um projeto de gra\u00e7a<\/a>ou navegue por nosso<a href=\"https:\/\/www.kolabtree.com\/find-an-expert?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> freelancers mais bem classificados<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Nare Simonyan, regulatory affairs and clinical trials specialist on Kolabtree, provides a Risk Management Plan (RMP) template that medical devices and pharma companies can use as a reference point for their product submissions. What is a Risk Management Plan (RMP)? A Risk Management Plan or RMP is a document that details the medicinal product&#8217;s safety<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":605,"featured_media":9463,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,317,247,443,540,653,516],"tags":[45,59,21,38],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Risk Management Plan (RMP) Template (FREE) -<\/title>\n<meta name=\"description\" content=\"Looking to draft a risk management plan? Here&#039;s a free reference RMP template drafted by our regulatory expert that you can use.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Risk Management Plan (RMP) Template (FREE)\" \/>\n<meta property=\"og:description\" content=\"Looking to draft a risk management plan? Here&#039;s a free reference RMP template drafted by our regulatory expert that you can use.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-risk-management-rmp-template-free\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2021-08-20T12:28:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-10T09:43:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/08\/RMP-Template.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Naren Madan\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Naren Madan\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Risk Management Plan (RMP) Template (FREE) -","description":"Looking to draft a risk management plan? 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