{"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\/es\/medical-device-risk-management-rmp-template-free\/","title":{"rendered":"Plantilla del Plan de Gesti\u00f3n de Riesgos M\u00e9dicos (RMP) (GRATIS)"},"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\">Tabla de contenidos<\/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-69f2e2b68540c\" aria-label=\"Tabla de contenidos\"><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-69f2e2b68540c\"><\/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\/es\/medical-device-risk-management-rmp-template-free\/#What_is_a_Risk_Management_Plan_RMP\" title=\"\u00bfQu\u00e9 es un plan de gesti\u00f3n de riesgos?\">\u00bfQu\u00e9 es un plan de gesti\u00f3n de riesgos?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/medical-device-risk-management-rmp-template-free\/#Why_do_you_need_an_RMP_template\" title=\"\u00bfPor qu\u00e9 necesita una plantilla de RMP?\">\u00bfPor qu\u00e9 necesita una plantilla de 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>especialista en asuntos regulatorios y ensayos cl\u00ednicos en Kolabtree, ofrece una <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\">Plan de gesti\u00f3n de riesgos<\/a> (RMP) que las empresas de productos sanitarios y farmac\u00e9uticos pueden utilizar como punto de referencia para la presentaci\u00f3n de sus productos.<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_Risk_Management_Plan_RMP\"><\/span>\u00bfQu\u00e9 es un plan de gesti\u00f3n de riesgos?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Un Plan de Gesti\u00f3n de Riesgos o RMP es un documento que detalla las caracter\u00edsticas de seguridad del medicamento, en particular las contingencias establecidas para reducir su gravedad de riesgo entre los pacientes. El modelo de plan de gesti\u00f3n de riesgos tambi\u00e9n requiere que las empresas expliquen c\u00f3mo participar\u00e1n en los estudios en curso para minimizar o prevenir los riesgos y mejorar la seguridad del medicamento.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_do_you_need_an_RMP_template\"><\/span>\u00bfPor qu\u00e9 necesita una plantilla de RMP?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Las empresas est\u00e1n obligadas a presentar un Plan de Gesti\u00f3n de Riesgos a los organismos m\u00e9dicos competentes, como la Agencia Europea de Medicamentos (EMA), mientras solicitan la autorizaci\u00f3n de comercializaci\u00f3n. Adem\u00e1s, cualquier autoridad nacional competente (ANC) puede solicitar un plan de gesti\u00f3n de riesgos para los productos m\u00e9dicos autorizados a nivel nacional.<\/p>\n<p>Esta plantilla gratuita de RMP le servir\u00e1 de punto de referencia cuando tenga que presentar un plan de gesti\u00f3n de riesgos para su nuevo producto.<\/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=\"69f2e2b66e9b7\"><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=\"69f2e2b66e9b7\" 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_69f2e2b66e9b7\" class=\"forminator-label\">Email Address <span class=\"forminator-required\">*<\/span><\/label><input type=\"email\" name=\"email-1\" value=\"\" placeholder=\"\" id=\"forminator-field-email-1_69f2e2b66e9b7\" 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\/es\/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\/es\/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=\"es\"\/><\/form><p>Esta plantilla de RMP ha sido redactada por Nare Simonyan, trabajador aut\u00f3nomo de Kolabtree. 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 aut\u00f3nomo en materia de reglamentaci\u00f3n<\/a> con un doctorado en ciencias farmac\u00e9uticas. Ofrece su experiencia como consultora en una amplia variedad de temas, como los ensayos cl\u00ednicos, el cumplimiento normativo, la redacci\u00f3n cient\u00edfica y la revisi\u00f3n m\u00e9dica. Contacte directamente con Nare <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">aqu\u00ed.<\/a><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Kolabtree<\/a> le ayuda a acceder directamente a una red mundial de expertos cient\u00edficos y de la industria. Nuestros expertos ofrecen servicios freelance en una amplia variedad de nichos de mercado. \u00bfQuiere contratar a un experto?<a href=\"https:\/\/www.kolabtree.com\/create-project?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> Publicar un proyecto gratis<\/a>o navegar a trav\u00e9s de nuestro<a href=\"https:\/\/www.kolabtree.com\/find-an-expert?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> aut\u00f3nomos mejor valorados<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Nare Simonyan, especialista en asuntos reglamentarios y ensayos cl\u00ednicos de Kolabtree, ofrece una plantilla de Plan de Gesti\u00f3n de Riesgos (PGR) que las empresas de productos sanitarios y farmac\u00e9uticos pueden utilizar como punto de referencia para la presentaci\u00f3n de sus productos. \u00bfQu\u00e9 es un plan de gesti\u00f3n de riesgos? Un Plan de Gesti\u00f3n de Riesgos o RMP es un documento que detalla la seguridad del medicamento<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/es\/medical-device-risk-management-rmp-template-free\/\" title=\"Leer m\u00e1s\">Leer m\u00e1s<\/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\/es\/medical-device-risk-management-rmp-template-free\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\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\/es\/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=\"Tiempo de lectura\" \/>\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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