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Podr\u00eda decirse que la gesti\u00f3n de se\u00f1ales es la actividad m\u00e1s importante de la farmacovigilancia. Al fin y al cabo, la raz\u00f3n de crear y poner en marcha un sistema de farmacovigilancia con todos sus procesos es identificar y evaluar los posibles riesgos para la seguridad y los cambios en el perfil beneficio-riesgo de los medicamentos comercializados. Eso es lo que se pretende conseguir con la detecci\u00f3n de se\u00f1ales, la validaci\u00f3n de se\u00f1ales y el an\u00e1lisis de se\u00f1ales. <\/p>\n
Con el sistema de farmacovigilancia Tepsivo, tendr\u00e1s la seguridad de que todos los datos relevantes para la seguridad se eval\u00faan diligentemente siguiendo nuestros procesos de gesti\u00f3n de se\u00f1ales.<\/p>\n
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Podr\u00eda decirse que la gesti\u00f3n de se\u00f1ales es la actividad m\u00e1s importante de la farmacovigilancia. Al fin y al cabo, la raz\u00f3n de crear y poner en marcha un sistema de farmacovigilancia con todos sus procesos es identificar y evaluar los posibles riesgos para la seguridad y los cambios en el perfil beneficio-riesgo de los medicamentos comercializados. Eso es lo que se pretende conseguir con la detecci\u00f3n de se\u00f1ales, la validaci\u00f3n de se\u00f1ales y el an\u00e1lisis de se\u00f1ales. <\/p>\n
Con el sistema de farmacovigilancia Tepsivo, tendr\u00e1s la seguridad de que todos los datos relevantes para la seguridad se eval\u00faan diligentemente siguiendo nuestros procesos de gesti\u00f3n de se\u00f1ales.<\/p>\n
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Como con cualquier otra parte de nuestro sistema y procesos de farmacovigilancia, realizamos las actividades de gesti\u00f3n de se\u00f1ales a trav\u00e9s de nuestra exclusiva Plataforma Tepsivo. Por su naturaleza de centralizar todas las actividades en curso y los datos recopilados en un solo lugar, nos permite acceder directamente al conjunto de datos que necesitamos para analizar cualquier informaci\u00f3n potencialmente relevante para el perfil de seguridad de tus medicamentos. <\/p>\n
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Gracias a nuestras herramientas y procesos, hemos eliminado decenas de horas que suelen necesitarse para el trabajo administrativo general en torno a la gesti\u00f3n de se\u00f1ales. Esto hace que nuestro an\u00e1lisis de datos sea mucho m\u00e1s f\u00e1cil y se centre en lo que importa, permiti\u00e9ndonos realizar una evaluaci\u00f3n cr\u00edtica de los datos de que disponemos. Adem\u00e1s, podemos vincular cualquier se\u00f1al validada con el desarrollo de PSUR\/PADER. <\/p>\n
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El objetivo principal es el mismo: identificar cualquier riesgo para la seguridad, analizarlo y, si es necesario, elevarlo a las autoridades y al p\u00fablico. Pero lo que es igual de importante es la capacidad de conseguirlo con la mayor eficacia posible, es decir, invirtiendo el menor tiempo y coste. Esto significa adoptar un enfoque pragm\u00e1tico y evitar cualquier tonter\u00eda, duplicar el trabajo para justificar m\u00e1s horas de trabajo, como es pr\u00e1ctica habitual en la mayor\u00eda de nuestros competidores. <\/p>\n
Aunque la gesti\u00f3n de las se\u00f1ales es crucial, la realidad es que en la mayor\u00eda de los casos es en gran medida s\u00f3lo una salvaguarda y de hecho se analizan pocos datos. En general, hay muy pocas se\u00f1ales v\u00e1lidas, lo que plantea la cuesti\u00f3n de si est\u00e1 justificado imponer requisitos de gesti\u00f3n de se\u00f1ales a los titulares de MA. S\u00ed, porque es una salvaguarda, y nunca se sabe… <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb3_5,2_5″ use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1″ _builder_version=\u00bb4.16″ width=\u00bb100%\u00bb max_width=\u00bb1050px\u00bb min_height=\u00bb332px\u00bb custom_margin=\u00bb0px|auto|22px|auto|false|false\u00bb custom_padding=\u00bb44px||0px|0px|false|false\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb3_5″ _builder_version=\u00bb4.16″ custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_image src=\u00bbhttps:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/signal-management-dashboards-transparent-background-full-size-picture-1024×724.png\u00bb title_text=\u00bbgesti\u00f3n-de-se\u00f1al-tableros-fondo-transparente-imagen-a-tama\u00f1o-completo\u00bb show_bottom_space=\u00bboff\u00bb align_tablet=\u00bbcenter\u00bb align_phone=\u00bbcenter\u00bb align_last_edited=\u00bbon|phone\u00bb disabled_on=\u00bboff|on|on\u00bb _builder_version=\u00bb4.16″ max_width=\u00bb88%\u00bb max_width_tablet=\u00bb49%\u00bb max_width_phone=\u00bb73%\u00bb max_width_last_edited=\u00bbon|phone\u00bb max_height=\u00bb340px\u00bb max_height_tablet=\u00bb307px\u00bb max_height_phone=\u00bb293px\u00bb max_height_last_edited=\u00bbon|phone\u00bb custom_margin=\u00bb31px||||false|false\u00bb custom_margin_tablet=\u00bb0px|0px|0px|0px|false|false\u00bb custom_margin_phone=\u00bb-15px||25px||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb6px|0px|8px|0px|false|false\u00bb custom_padding_tablet=\u00bb0px|0px|0px|0px|false|false\u00bb custom_padding_phone=\u00bb0px||5px|4px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb module_alignment_tablet=\u00bbcenter\u00bb module_alignment_phone=\u00bbcenter\u00bb module_alignment_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16″ text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_font=\u00bb||||||||\u00bb header_4_font=\u00bbMontserrat|600|||||||\u00bb header_4_text_color=\u00bb#312533″ header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb text_orientation=\u00bbjustified\u00bb max_width=\u00bb600px\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb3px|||0px|false|false\u00bb custom_padding=\u00bb34px|45px|79px|0px|false|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb15px|25px|0px|25px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb header_4_font_size_phone=\u00bb20px\u00bb header_4_font_size_last_edited=\u00bboff|desktop\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n …PERO, y esto es vital, debemos seguir siendo pr\u00e1cticos y adoptar un enfoque sensato al analizar los datos, eligiendo una frecuencia l\u00f3gica y las fuentes adecuadas. Esto es contrario a la pr\u00e1ctica del sector, donde la se\u00f1alizaci\u00f3n puede llevar a veces semanas de trabajo con diferentes rastreadores, registros, reuniones e informes cada trimestre, que al final no muestran ninguna se\u00f1al v\u00e1lida. A menudo, todo ello en un intento de justificar una mayor carga de trabajo… <\/p>\n Ninguno de estos m\u00e9todos anticuados funciona con nosotros. En el sistema de farmacovigilancia Tepsivo, realizamos la gesti\u00f3n de se\u00f1ales prestando la m\u00e1xima atenci\u00f3n a los detalles, siempre que sean relevantes. 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custom_padding=\u00bb0px||20px||false|false\u00bb border_radii=\u00bbon|10px|10px|10px|10px\u00bb box_shadow_style=\u00bbpreset1″ box_shadow_color=\u00bbrgba(0,0,0,0.1)\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16″ header_line_height=\u00bb1.8em\u00bb header_4_font=\u00bbMontserrat|700|||||||\u00bb header_4_text_color=\u00bb#7f7f7f\u00bb header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb custom_padding=\u00bb30px|32px|12px|32px|false|true\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n Somos parte interesada en el sector de la FV como proveedor de farmacovigilancia, y tambi\u00e9n somos conocidos por nuestra cr\u00edtica sincera del panorama actual de la farmacovigilancia, especialmente en Europa. Estamos convencidos de que los procesos est\u00e1ndar existentes son muy ineficaces y los legisladores europeos y la EMA no han aplicado ninguna m\u00e9trica de la eficacia de los procesos. <\/p>\n Pero a su favor hay que decir que, en Europa, la EMA ha centralizado gran parte de los requisitos generales de gesti\u00f3n de se\u00f1ales con su programa piloto, en el que la mayor\u00eda de los titulares de autorizaci\u00f3n de comercializaci\u00f3n ya no est\u00e1n obligados a supervisar continuamente los datos de EudraVigilance, lo que les libera de una importante carga de trabajo. A menos que tu medicamento est\u00e9 en la lista piloto de la EMA, tus actividades reales de gesti\u00f3n de se\u00f1ales pueden ser, de hecho, bastante limitadas. <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb<\/p>\n Por eso es importante que elijas al proveedor de farmacovigilancia adecuado, que pueda guiarte por el proceso de gesti\u00f3n de se\u00f1ales teniendo en cuenta tus intereses, de la forma m\u00e1s eficaz posible y sin duplicidades.<\/p>\n La realidad es que muchos vendedores de ah\u00ed fuera siguen realizando descargas semanales regulares de EV, aunque t\u00fa como MAH (probablemente) no tengas esa obligaci\u00f3n, y puedes adivinar por qu\u00e9… (\u20ac)<\/p>\n Por supuesto, eso no ocurre en Tepsivo. Todos nuestros procesos y herramientas de farmacovigilancia, incluidos los m\u00f3dulos de gesti\u00f3n de se\u00f1ales, an\u00e1lisis y validaci\u00f3n de nuestra Plataforma Tepsivo, ofrecen el servicio m\u00e1s eficaz y de mayor calidad. <\/p>\n \u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16″ header_4_font=\u00bbMontserrat|700|||||||\u00bb header_4_text_color=\u00bb#7f7f7f\u00bb header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb custom_padding=\u00bb30px|39px||12px|false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb|32px|25px|32px|false|true\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n Por eso es importante que elijas al proveedor de farmacovigilancia adecuado, que pueda guiarte por el proceso de gesti\u00f3n de se\u00f1ales teniendo en cuenta tus intereses, de la forma m\u00e1s eficaz posible y sin duplicidades.<\/p>\n La realidad es que muchos vendedores de ah\u00ed fuera siguen realizando descargas semanales regulares de EV, aunque t\u00fa como MAH (probablemente) no tengas esa obligaci\u00f3n, y puedes adivinar por qu\u00e9… (\u20ac)<\/p>\n Por supuesto, eso no ocurre en Tepsivo. Todos nuestros procesos y herramientas de farmacovigilancia, incluidos los m\u00f3dulos de gesti\u00f3n de se\u00f1ales, an\u00e1lisis y validaci\u00f3n de nuestra Plataforma Tepsivo, ofrecen el servicio m\u00e1s eficaz y de mayor calidad. <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.16″ custom_margin=\u00bb0px||||false|false\u00bb custom_padding=\u00bb15px||21px||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16″ custom_padding=\u00bb||1px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16″ custom_margin=\u00bb||10px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n Lectura relacionada sobre gesti\u00f3n de se\u00f1ales y an\u00e1lisis de datos escrita por nuestro Director de Operaciones Martti Ahtola:<\/p>\n [\/et_pb_text][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16″ text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_font=\u00bb||||||||\u00bb header_4_font=\u00bbMontserrat|600|||||||\u00bb header_4_text_color=\u00bb#312533″ header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb text_orientation=\u00bbjustified\u00bb max_width=\u00bb837px\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb-11px||13px|0px|false|false\u00bb custom_padding=\u00bb17px|27px|3px|27px|false|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb15px|0px||0px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb header_4_font_size_phone=\u00bb20px\u00bb header_4_font_size_last_edited=\u00bboff|desktop\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n \u00abAn\u00e1lisis de la se\u00f1al de seguridad potencial\u00bb (art\u00edculo en TechnologyNetworks.com)<\/a><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.16″ background_color=\u00bb#0c9cd1″ use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#F4F5F7 0%|#F4F5F7 100%\u00bb background_color_gradient_start=\u00bb#F4F5F7″ background_color_gradient_end=\u00bb#F4F5F7″ custom_margin=\u00bb-1px||||false|false\u00bb custom_padding=\u00bb0px||21px||false|false\u00bb top_divider_style=\u00bbmountains2″ top_divider_color=\u00bb#ffffff\u00bb top_divider_height=\u00bb75px\u00bb top_divider_flip=\u00bbhorizontal\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16″ custom_padding=\u00bb92px|||||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.16″ custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_text _builder_version=\u00bb4.16″ text_font=\u00bbMontserrat||||||||\u00bb text_font_size=\u00bb18px\u00bb text_line_height=\u00bb2em\u00bb ul_font=\u00bb||||||||\u00bb ol_font=\u00bb||||||||\u00bb header_font=\u00bb||||||||\u00bb header_2_font=\u00bbMontserrat|700|||||||\u00bb header_2_font_size=\u00bb36px\u00bb header_2_line_height=\u00bb1.6em\u00bb header_3_font=\u00bbMerriweather|700|||||||\u00bb header_3_text_color=\u00bb#ffc47c\u00bb header_3_font_size=\u00bb18px\u00bb header_3_line_height=\u00bb1.8em\u00bb header_4_font=\u00bb||||||||\u00bb header_5_font=\u00bb||||||||\u00bb header_6_font=\u00bb||||||||\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||5px|||\u00bb header_2_font_size_tablet=\u00bb\u00bb header_2_font_size_phone=\u00bb28px\u00bb header_2_font_size_last_edited=\u00bbon|phone\u00bb header_3_font_size_tablet=\u00bb\u00bb header_3_font_size_phone=\u00bb14px\u00bb header_3_font_size_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=\u00bb4.16″ text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_line_height=\u00bb1.5em\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n Sean cuales sean tus necesidades, estamos deseando ponernos en contacto contigo. [\/et_pb_text][et_pb_button button_url=\u00bbhttps:\/\/www.tepsivo.com\/es\/reserva-una-consulta-gratuita-de-15-minutos\/\u00bb button_text=\u00bbReserva GRATIS una consulta de 15 minutos\u00bb button_alignment=\u00bbcenter\u00bb module_class=\u00bbprimary-button\u00bb _builder_version=\u00bb4.16″ custom_button=\u00bbon\u00bb button_text_size=\u00bb16px\u00bb button_text_color=\u00bb#b5302f\u00bb button_bg_color=\u00bb#ffffff\u00bb button_border_width=\u00bb2px\u00bb button_border_color=\u00bb#ffffff\u00bb button_border_radius=\u00bb19px\u00bb button_font=\u00bbMontserrat||||||||\u00bb button_use_icon=\u00bboff\u00bb custom_margin=\u00bb|10px||0px|false|false\u00bb custom_padding=\u00bb9px|30px|9px|30px|true|false\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][et_pb_button button_url=\u00bbhttps:\/\/www.tepsivo.com\/es\/ponte-en-contacto-con\/\u00bb button_text=\u00bbDeja un mensaje\u00bb button_alignment=\u00bbcenter\u00bb module_class=\u00bbsecondary-button\u00bb _builder_version=\u00bb4.16″ custom_button=\u00bbon\u00bb button_text_size=\u00bb16px\u00bb button_text_color=\u00bb#ffffff\u00bb button_bg_color=\u00bb#b5302f\u00bb button_border_width=\u00bb2px\u00bb button_border_color=\u00bb#b5302f\u00bb button_border_radius=\u00bb19px\u00bb button_font=\u00bbMontserrat||||||||\u00bb button_use_icon=\u00bboff\u00bb custom_margin=\u00bb|10px||0px|false|false\u00bb custom_padding=\u00bb9px|80px|9px|80px|false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb9px|45px|9px|45px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.16″ background_color=\u00bb#F4F5F7″ custom_padding=\u00bb5px||0px|||\u00bb border_color_all=\u00bb#8F909D\u00bb border_width_top=\u00bb1px\u00bb border_style_top=\u00bbdashed\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16″ custom_padding=\u00bb15px||14px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.27.4″ text_font=\u00bbMontserrat||||||||\u00bb text_orientation=\u00bbcenter\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0″]<\/p>\n Tepsivo Oy | Haartmaninkatu 4, Edificio 14, 00290, Helsinki, Finlandia<\/span> | N\u00famero de IVA FI31367614 | contact@tepsivo.com <\/a>| +358 402 204 698 | Pol\u00edtica de privacidad<\/u><\/a><\/p>\n \nM\u00e1s informaci\u00f3n sobre nuestro enfoque
\n a la gesti\u00f3n de se\u00f1ales<\/h2>\nM\u00e1s informaci\u00f3n sobre nuestro enfoque
\n a la gesti\u00f3n de se\u00f1ales<\/h2>\nM\u00e1s informaci\u00f3n sobre nuestro enfoque
\n a la gesti\u00f3n de se\u00f1ales<\/h2>\nProvocar cambios en el sistema fotovoltaico<\/h4>\n
Maximizar la eficacia, no las horas facturables<\/h4>\n
Maximizar la eficacia, no las horas facturables<\/h4>\n
Charlemos<\/h2>\n
\nNo dudes en enviarnos un mensaje y nos pondremos en contacto contigo enseguida.<\/p>\n