{"id":57192,"date":"2022-05-27T12:06:02","date_gmt":"2022-05-27T10:06:02","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/cribado-y-gestion-de-la-literatura-para-actividades-de-farmacovigilancia\/"},"modified":"2022-05-27T12:06:02","modified_gmt":"2022-05-27T10:06:02","slug":"cribado-y-gestion-de-la-literatura-para-actividades-de-farmacovigilancia","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/cribado-y-gestion-de-la-literatura-para-actividades-de-farmacovigilancia\/","title":{"rendered":"Cribado y gesti\u00f3n de la literatura para actividades de farmacovigilancia"},"content":{"rendered":"<p>Los ensayos cl\u00ednicos solo pueden mostrar los resultados de aplicar medicamentos o dispositivos terap\u00e9uticos a miembros de una poblaci\u00f3n controlada, normalmente en entornos controlados. Sin embargo, una vez que el producto se aprueba para su comercializaci\u00f3n, es inevitable que exista alg\u00fan tipo de variaci\u00f3n en c\u00f3mo lo toleran distintas personas. Por ello, la <a href=\"https:\/\/gxp-training.com\/es\/online-course\/buenas-practicas-de-farmacovigilancia-gvp\/\">farmacovigilancia<\/a> es una extensi\u00f3n necesaria del proceso de descubrimiento de f\u00e1rmacos, en la que se monitoriza en el mundo real el uso de un nuevo f\u00e1rmaco o dispositivo.  <\/p>\n<p>Este curso presenta al alumnado los distintos informes utilizados para recopilar datos para la farmacovigilancia activa y pasiva, y se\u00f1ala la relevancia de organismos como la FDA y la MHRA en la recopilaci\u00f3n de dicha informaci\u00f3n.<\/p>\n<p>&nbsp;<\/p>\n<p>En este curso ofrecemos una s\u00edntesis del tema a trav\u00e9s de una experiencia online interactiva. Este material fue elaborado por un equipo de expertos en Asuntos Regulatorios con una titulaci\u00f3n de Northeastern University, Boston, y pilotado por un miembro s\u00e9nior capaz de articular la teor\u00eda con la pr\u00e1ctica. <\/p>\n<p>&nbsp;<\/p>\n<h3><\/h3>\n<h3>Programa<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Objetivos de la farmacovigilancia<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Cribado de la literatura cient\u00edfica con fines de farmacovigilancia<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Papel de la literatura cient\u00edfica y m\u00e9dica en la farmacovigilancia<\/li>\n<li>Vigilancia pasiva (farmacovigilancia)<\/li>\n<li>Notificaci\u00f3n espont\u00e1nea de reacciones adversas a medicamentos<\/li>\n<li>Identificaci\u00f3n de se\u00f1ales de seguridad para la notificaci\u00f3n espont\u00e1nea<\/li>\n<li>Informes de series de casos<\/li>\n<li>Evaluaci\u00f3n de la causalidad<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Informes resumidos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Informes peri\u00f3dicos de actualizaci\u00f3n de seguridad<\/li>\n<li>El valor de los <a href=\"https:\/\/gxp-training.com\/online-course\/gxp1861-management-of-periodic-safety-update-reports\/\">informes peri\u00f3dicos de actualizaci\u00f3n de seguridad<\/a><\/li>\n<li>Informe peri\u00f3dico de evaluaci\u00f3n beneficio-riesgo<\/li>\n<li>Utilidad del informe peri\u00f3dico de evaluaci\u00f3n beneficio-riesgo<\/li>\n<li>El plan de gesti\u00f3n de riesgos<\/li>\n<li>Las actividades de minimizaci\u00f3n de riesgos<\/li>\n<li>Especificaciones de farmacovigilancia<\/li>\n<li>Utilidad del plan de gesti\u00f3n de riesgos<\/li>\n<li>Informe de actualizaci\u00f3n de seguridad del desarrollo<\/li>\n<li>La utilidad del informe de actualizaci\u00f3n de seguridad del desarrollo<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Vigilancia activa (farmacovigilancia)<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Registros de pacientes<\/li>\n<li>Actividades de farmacovigilancia<\/li>\n<li>Enfoque conceptual: \u00e1reas clave para medir el impacto de las actividades de farmacovigilancia<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Eficacia de las actividades de minimizaci\u00f3n de riesgos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Eficacia de procesos espec\u00edficos de farmacovigilancia<\/li>\n<li>Factores facilitadores de la eficacia en farmacovigilancia<\/li>\n<li>Identificaci\u00f3n y desarrollo de m\u00e9todos anal\u00edticos<\/li>\n<li>\u00bfPor qu\u00e9 cribar la literatura m\u00e9dica para identificar reacciones adversas a medicamentos individuales?<\/li>\n<li>\u00bfPor qu\u00e9 buscar en la literatura?<\/li>\n<li>La literatura como fuente de RAM: talidomida y defectos cong\u00e9nitos<\/li>\n<li>Retos del cribado de la literatura cient\u00edfica y m\u00e9dica para la farmacovigilancia<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Diferencias en la normativa<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>C\u00f3mo elaborar la estrategia de b\u00fasqueda perfecta<\/li>\n<li>El gran volumen de literatura cient\u00edfica<\/li>\n<li>Inspecciones y auditor\u00edas<\/li>\n<li>Seguimiento de revistas en idiomas locales<\/li>\n<li>Implementaci\u00f3n de los resultados de EMA MLM<\/li>\n<li>Argumentos a favor de la externalizaci\u00f3n<\/li>\n<li>La externalizaci\u00f3n no est\u00e1 exenta de riesgos<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 6: Soluciones de software para la gesti\u00f3n de la literatura<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Soluci\u00f3n de gesti\u00f3n de la literatura: mejore la gesti\u00f3n del flujo de trabajo y el cumplimiento normativo<\/li>\n<li>Soluci\u00f3n online de gesti\u00f3n de la informaci\u00f3n<\/li>\n<li>\u00bfQu\u00e9 hace QUOSA?<\/li>\n<li>\u00bfPara qui\u00e9n es QUOSA?<\/li>\n<li>\u00bfPor qu\u00e9 elegir QUOSA?<\/li>\n<li>\u00bfC\u00f3mo funciona QUOSA?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Acr\u00f3nimos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Evaluaci\u00f3n<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los ensayos cl\u00ednicos solo pueden mostrar los resultados de aplicar medicamentos o dispositivos terap\u00e9uticos a miembros de una poblaci\u00f3n controlada, normalmente en entornos controlados. Sin embargo, una vez que el producto se aprueba para su comercializaci\u00f3n, es inevitable que exista alg\u00fan tipo de variaci\u00f3n en c\u00f3mo lo toleran distintas personas. Por ello, la farmacovigilancia es [&hellip;]<\/p>\n","protected":false},"featured_media":44663,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[268,270,269],"product_tag":[],"class_list":{"0":"post-57192","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-farmacovigilancia","7":"product_cat-organizacion-de-investigacion-por-contrato-cro","8":"product_cat-productos-farmaceuticos","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Literatura de farmacovigilancia: curso online y certificaci\u00f3n<\/title>\n<meta name=\"description\" content=\"Aprenda a utilizar la literatura de forma adecuada para la farmacovigilancia. 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