{"id":8522,"date":"2018-12-06T11:21:39","date_gmt":"2018-12-06T10:21:39","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8522"},"modified":"2023-01-26T13:41:04","modified_gmt":"2023-01-26T12:41:04","slug":"la-persona-responsable-la-formacion-del-experto-en-asuntos-regulatorios","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/12\/06\/la-persona-responsable-la-formacion-del-experto-en-asuntos-regulatorios\/","title":{"rendered":"La Persona Responsable: la formaci\u00f3n del experto en asuntos regulatorios"},"content":{"rendered":"\r\n<div class=\"wp-block-image\">\r\n<figure class=\"aligncenter\"><img decoding=\"async\" class=\"wp-image-8511\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/12\/PRRC.jpg\" alt=\"\" \/><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<p>Inspirado en el papel de la \u00abPersona cualificada \u00bb (<em>Qualified Person<\/em>) presente en el sector farmac\u00e9utico, el concepto de Persona Responsable en cumplimiento de la ley es una de las novedades introducidas por este importante cambio en el marco legislativo europeo, el MDR (UE) 2017\/745.\u00a0 Este cambio tiene un impacto significativo no solo en la actividad de los Fabricantes de dispositivos m\u00e9dicos, sino tambi\u00e9n en los Representantes Autorizados en la Uni\u00f3n Europea.<\/p>\r\n\r\n\r\n\r\n<p>Sin embargo, la presencia de la figura profesional del\u00a0<strong>experto en asuntos regulatorios\u00a0<\/strong>en las empresas productoras de dispositivos m\u00e9dicos no es nueva. Los Fabricantes a menudo han confiado la tarea de asegurar la conformidad de sus productos con las normas vigentes a un departamento interno (al director t\u00e9cnico o al gestor de calidad) o a consultores externos.<\/p>\r\n\r\n\r\n\r\n<p>La entrada en vigor del Reglamento no solo introduce el <strong>reconocimiento oficial <\/strong>de esta figura, sino que establece su presencia obligatoria dentro de las empresas del sector.\u00a0 De hecho, el Art\u00edculo 15 est\u00e1 completamente dedicado a definir los requisitos, tareas y deberes de la Persona Responsable.<\/p>\r\n\r\n\r\n\r\n<p>La persona a cargo del cumplimiento normativo asume un mayor papel de responsabilidad. En particular, sus responsabilidades incluyen:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Verificar el cumplimiento de los dispositivos con el sistema de gesti\u00f3n de calidad antes de su lanzamiento;<\/li>\r\n<li>Verificar que la documentaci\u00f3n t\u00e9cnica y la declaraci\u00f3n de conformidad de la UE est\u00e9n redactadas y actualizadas.<\/li>\r\n<li>Gestionar las obligaciones de vigilancia posterior a la comercializaci\u00f3n y garantizar su cumplimiento;<\/li>\r\n<li>Gestionar las obligaciones de informaci\u00f3n y garantizar su cumplimiento.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>En un campo en constante cambio como \u00e9l de los DM e IVD y considerando el escenario que se implementar\u00e1 pronto, este rol requerir\u00e1 una experiencia espec\u00edfica cada vez mayor, por lo que la Direcci\u00f3n tendr\u00e1 que tener en cuenta un presupuesto recurrente para garantizar su capacitaci\u00f3n constante y continua.<\/p>\r\n\r\n\r\n\r\n<p>El candidato ideal para este rol debe ser un experto en comunicaci\u00f3n multidisciplinaria e interfuncional, que act\u00fae como\u00a0enlace entre los distintos departamentos de la empresa, asegurando el intercambio de informaci\u00f3n. Adem\u00e1s, su funci\u00f3n es estrat\u00e9gica: debe interactuar con la Direcci\u00f3n, proporcionando indicaciones para la estrategia comercial actual y futura y fomentar decisiones correctas sobre los productos fabricados.<\/p>\r\n\r\n\r\n\r\n<p>La formaci\u00f3n de esta figura supone una mayor inversi\u00f3n econ\u00f3mica por parte de la organizaci\u00f3n. Sin embargo, una persona calificada y competente guiar\u00e1 a la empresa hacia una mejor gesti\u00f3n y representar\u00e1 una garant\u00eda de la seguridad y la eficacia del producto.<\/p>\r\n\r\n\r\n\r\n<p>En conclusi\u00f3n, tener una <strong>persona altamente calificada, competente y actualizada\u00a0<\/strong>que desempe\u00f1e el papel de persona responsable puede marcar la diferencia entre permanecer en el mercado de dispositivos m\u00e9dicos o no.<\/p>\r\n\r\n\r\n\r\n<p><strong>\u00bfYa has empezado a formar la tuya?<\/strong><\/p>\r\n\r\n\r\n\n<div class=\"wp-block-media-text alignwide\" style=\"grid-template-columns:20% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/10\/thema-group.png\" alt=\"\" class=\"wp-image-8090\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p><strong><em>Otilia Maya Tanase, PhD<\/em><\/strong> <br><em>Regulatory Affairs &amp; Marketing Specialist<\/em> <br><\/p>\n<\/div><\/div>\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Fuentes:<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Reglamento dispositivos m\u00e9dicos (UE) 2017\/745<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p><em>Thema Srl se dedica con pasi\u00f3n a salvar vidas y preservar la salud de hombres, mujeres, ni\u00f1os y animales. Nuestros conocimientos nos permiten ser el socio ideal de las empresas para la formaci\u00f3n de profesionales en el sector, garantizando la optimizaci\u00f3n de tiempo y recursos.<\/em><\/p>\r\n\r\n\r\n\r\n<p>\u00bfHas leido el art\u00edculo en nuestro blog \u00ab<a href=\"http:\/\/www.thema-med.com\/valutazione-clinica-il-vostro-rapporto-di-valutazione-clinica-cer-e-conforme-alla-meddev-2-7-1-rev-4\/\">Evaluaci\u00f3n cl\u00ednica: el informe de evaluaci\u00f3n cl\u00ednica (CER) cumple con la Directriz MEDDEV 2.7\/1 rev.\u00a0 4?\u00a0<\/a>\u00bb y descargado la \u00ab<a href=\"http:\/\/www.thema-med.com\/infografica-della-valutazione-clinica\/\">Infograf\u00eda de la Evaluaci\u00f3n Cl\u00ednica<\/a>\u201d?<\/p>\r\n\r\n\r\n\r\n<p>Descarga nuestro informe t\u00e9cnico \u201c<a href=\"http:\/\/www.thema-med.com\/es\/nanomateriales-evaluacion-de-la-seguridad-y-del-riesgo-en-los-dispositivos-medicos\/\" target=\"_blank\" rel=\"noopener\">Nanomateriales: evaluaci\u00f3n de la seguridad y del riesgo en los dispositivos m\u00e9dicos<\/a>\u201d y profundiza los cambios adoptados por el Reglamento MDR (UE) 2017\/745.<\/p>\r\n\r\n\r\n\r\n<p>\u00bfQuieres estar siempre al d\u00eda de las actividades de Thema? <a href=\"http:\/\/www.thema-med.com\/\">Suscr\u00edbete a nuestro bolet\u00edn de noticias<\/a>!<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Inspirado en el papel de la \u00abPersona cualificada \u00bb (Qualified Person) presente en el sector farmac\u00e9utico, el concepto de Persona Responsable  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":22551,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[680],"tags":[],"class_list":["post-8522","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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