{"id":57697,"date":"2023-03-13T15:48:58","date_gmt":"2023-03-13T15:48:58","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/redaccion-medica-del-informe-periodico-de-evaluacion-beneficio-riesgo-pbrer\/"},"modified":"2023-03-13T15:48:58","modified_gmt":"2023-03-13T14:48:58","slug":"redaccion-medica-del-informe-periodico-de-evaluacion-beneficio-riesgo-pbrer","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/redaccion-medica-del-informe-periodico-de-evaluacion-beneficio-riesgo-pbrer\/","title":{"rendered":"Redacci\u00f3n m\u00e9dica del Informe Peri\u00f3dico de Evaluaci\u00f3n Beneficio-Riesgo (PBRER)"},"content":{"rendered":"<p>El Informe Peri\u00f3dico de Evaluaci\u00f3n Beneficio-Riesgo o PBRER es un documento regulatorio utilizado como est\u00e1ndar com\u00fan para la evaluaci\u00f3n peri\u00f3dica beneficio-riesgo de productos comercializados en las regiones ICH. Los titulares de la autorizaci\u00f3n de comercializaci\u00f3n (TAC) preparan el PBRER para productos farmac\u00e9uticos espec\u00edficos que necesitan aprobaci\u00f3n para su lanzamiento al mercado y lo presentan a las autoridades reguladoras, como la FDA y la EMA. Un Informe Peri\u00f3dico de Evaluaci\u00f3n Beneficio-Riesgo resume el an\u00e1lisis de eventos adversos, nuevas preocupaciones de seguridad y revisiones del perfil beneficio-riesgo del producto. As\u00ed, un PBRER revisa la seguridad y eficacia de un producto farmac\u00e9utico durante un per\u00edodo de tiempo espec\u00edfico. Tambi\u00e9n revisa los cambios realizados en un producto en particular o en su etiquetado.    <\/p>\n<div class=\"noOutline\" data-ba-index=\"3\" data-ba=\"lessonEdit.block\" data-block-id=\"cley39xfj000n286dzitfhuq4\">\n<div>\n<div class=\"block-text block-text--heading \">\n<div class=\"block-text__container\" data-ba=\"blocks.blockText\">\n<div class=\"block-text__row\">\n<div class=\"block-text__col brand--head\">\n<div class=\" brand--linkColor\">\n<div class=\"fr-view\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>En este curso, le 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 cualificaci\u00f3n de la 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>Plan de estudios:<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Formato de redacci\u00f3n para PBRER<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Contenido de redacci\u00f3n para PBRER<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Redacci\u00f3n de la Conclusi\u00f3n y Ap\u00e9ndices<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/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>El Informe Peri\u00f3dico de Evaluaci\u00f3n Beneficio-Riesgo o PBRER es un documento regulatorio utilizado como est\u00e1ndar com\u00fan para la evaluaci\u00f3n peri\u00f3dica beneficio-riesgo de productos comercializados en las regiones ICH. Los titulares de la autorizaci\u00f3n de comercializaci\u00f3n (TAC) preparan el PBRER para productos farmac\u00e9uticos espec\u00edficos que necesitan aprobaci\u00f3n para su lanzamiento al mercado y lo presentan a [&hellip;]<\/p>\n","protected":false},"featured_media":43469,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,268,270,269],"product_tag":[],"class_list":{"0":"post-57697","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-asuntos-regulatorios","7":"product_cat-farmacovigilancia","8":"product_cat-organizacion-de-investigacion-por-contrato-cro","9":"product_cat-productos-farmaceuticos","11":"first","12":"instock","13":"taxable","14":"shipping-taxable","15":"purchasable","16":"product-type-simple"},"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>PBRER y redacci\u00f3n m\u00e9dica: curso online y certificaci\u00f3n<\/title>\n<meta name=\"description\" content=\"Curso online y certificaci\u00f3n en redacci\u00f3n m\u00e9dica del Informe Peri\u00f3dico de Evaluaci\u00f3n Beneficio-Riesgo (PBRER). 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