{"id":1648,"date":"2021-03-16T16:11:00","date_gmt":"2021-03-16T21:11:00","guid":{"rendered":"https:\/\/fifarma.org\/?p=1648"},"modified":"2023-04-02T08:04:12","modified_gmt":"2023-04-02T13:04:12","slug":"fifarma-participa-en-la-conferencia-regulatoria-latinoamericana-2021","status":"publish","type":"post","link":"https:\/\/fifarma.org\/en\/fifarma-participa-en-la-conferencia-regulatoria-latinoamericana-2021\/","title":{"rendered":"FIFARMA participa en la conferencia regulatoria latinoamericana 2021"},"content":{"rendered":"<p>Con m\u00e1s de 100 participantes representando a las agencias reguladoras, la industria y la academia de pr\u00e1cticamente todos los pa\u00edses de las Am\u00e9ricas, se celebr\u00f3 virtualmente, del 22 al 24 de febrero, la DIA Latin American Regulatory Conference (Conferencia Regulatoria Latinoamericana de la Asociaci\u00f3n de Informaci\u00f3n sobre Medicamentos -DIA).<\/p>\n\n\n\n<p>Durante la Conferencia expertos \u2013 con diferentes trayectorias y procedentes de distintos pa\u00edses \u2013 compartieron sobre algunas de las tendencias y retos mundiales actuales en materia de regulaci\u00f3n. Los participantes tuvieron la oportunidad de entender c\u00f3mo estas tendencias y desaf\u00edos encajan en el entorno regulatorio regional, y c\u00f3mo algunos de estos podr\u00edan representar oportunidades de acci\u00f3n, en beneficio de los pacientes de Am\u00e9rica Latina y el Caribe. La Conferencia cont\u00f3 con presentaciones de agencias reguladoras de Argentina, Bolivia, Brasil, Chile, CARICOM, Ecuador, Europa, Honduras, Paraguay, Per\u00fa y Estados Unidos.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"572\" src=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/DIA-LARC-1024x572-1.jpg\" alt=\"\" class=\"wp-image-1650\" srcset=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/DIA-LARC-1024x572-1.jpg 1024w, https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/DIA-LARC-1024x572-1-300x168.jpg 300w, https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/DIA-LARC-1024x572-1-768x429.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>Las sesiones permitieron comprender mejor c\u00f3mo promover una mayor eficiencia normativa, con la adopci\u00f3n de enfoques de fiabilidad, con la adecuada gesti\u00f3n del ciclo de vida de los productos y con requisitos normativos que coinciden con las directrices y normas internacionales. Las presentaciones destacaron el importante papel que desempe\u00f1an estos elementos para superar la emergencia sanitaria a la que se enfrenta el mundo en la actualidad. Otros temas de la agenda fueron el papel clave que desempe\u00f1a el etiquetado electr\u00f3nico para mejorar la seguridad de los pacientes, as\u00ed como las formas innovadoras en que la industria y las agencias reguladoras pueden responder a las nuevas demandas y a las nuevas tecnolog\u00edas en el \u00e1mbito de la fabricaci\u00f3n y los ensayos cl\u00ednicos.<\/p>\n\n\n\n<p>FIFARMA estuvo representada en dos sesiones por la Dra. Rebecca Lumsden, Co-Chair del Grupo de Regulatorio y Biol\u00f3gicos. En la segunda sesi\u00f3n se habl\u00f3 de la dependencia regulatoria, la cual fue liderada por la Sra. Cammilla Gomes, miembro del Grupo de R&amp;B de FIFARMA y donde participo el Dr. Samvel Azatyan de la Organizaci\u00f3n Mundial de la Salud (OMS) como ponente. En esta sesi\u00f3n, FIFARMA se uni\u00f3 a la Coalici\u00f3n Interamericana para la Convergencia Regulatoria del Sector de la Tecnolog\u00eda M\u00e9dica para presentar&nbsp;<a href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2021\/03\/Presentation-Session-2.pdf\" rel=\"noreferrer noopener\" target=\"_blank\"><strong>una perspectiva consolidada de la industria sobre el fortalecimiento de los sistemas regulatorios<\/strong><\/a>. El mensaje de la industria fue que, cuando se implementan de forma \u00f3ptima, los mecanismos de confianza permiten reforzar de capacidad reglamentaria, fortalecer los sistemas de regulaci\u00f3n, aumentar la seguridad p\u00fablica y garantizar el acceso sostenible a tratamientos m\u00e9dicos innovadores.<\/p>\n\n\n\n<p>La sesi\u00f3n 8 se centr\u00f3 en la convergencia reglamentaria y fue liderada por la Sra. Cristina Mota Pina, miembro de R&amp;B de FIFARMA. Los participantes oyeron las presentaciones de ponentes como la Dra. Agnes Saint-Raymond, directora de la Divisi\u00f3n de Asuntos Internacionales de la Agencia Europea de Medicamentos (EMA). Asimismo, FIFARMA&nbsp;<a href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2021\/03\/Presentation-Session-8.pdf\" rel=\"noreferrer noopener\" target=\"_blank\"><strong>present\u00f3 las perspectivas de la industria farmac\u00e9utica sobre la convergencia regulatoria que se produjo durante la pandemia<\/strong><\/a>, incluyendo las medidas adoptadas por el sector regulado para apoyar a los gobiernos en la respuesta a la crisis de la COVID-19.<\/p>\n\n\n\n<p>Estas presentaciones se basaron en las actividades del Grupo de Regulaci\u00f3n y Biol\u00f3gicos de FIFARMA y en los siguientes documentos de posici\u00f3n:&nbsp;<a href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2021\/01\/PAPER-RELIANCE.pdf\" rel=\"noreferrer noopener\" target=\"_blank\">\u201cConsideraciones para la utilizaci\u00f3n efectiva de decisiones regulatorias de otras jurisdicciones (\u201cReliance\u201d) por parte de las Agencias Regulatorias en la Regi\u00f3n de Am\u00e9rica Latina: Perspectiva de la Industria\u201d<\/a>&nbsp;y&nbsp;<a href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2020\/10\/COVID19-Espanol.pdf\" rel=\"noreferrer noopener\" target=\"_blank\">\u201cAsuntos regulatorios en el contexto de las emergencias sanitarias \u2013 Posibles enfoques para abordar los retos en la regi\u00f3n de Latinoam\u00e9rica y el Caribe\u201d<\/a>. Elementos del documento de posici\u00f3n de FIFARMA titulado&nbsp;<a href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2020\/08\/Terapias_avanzadas_Espanol.pdf\" rel=\"noreferrer noopener\" target=\"_blank\">\u201cPosicionamiento de FIFARMA \u2013 Acerca del potencial de las denominadas \u201cterapias avanzadas\u201d<\/a>, tambi\u00e9n fueron abordados por uno de los ponentes de la industria. Otros miembros del Grupo de Regulaci\u00f3n y Biol\u00f3gicos que participaron en la organizaci\u00f3n de la Conferencia son la Sra. Sonia Viejobueno, el Sr. Leonardo Semprum y la Sra. Maria Guazzaroni Jacobs.<\/p>\n\n\n\n<p>El mensaje general de FIFARMA fue que los conceptos de confianza, convergencia y armonizaci\u00f3n regulatoria est\u00e1n estrechamente relacionados y representan el futuro de la regulaci\u00f3n mundial, al tiempo que son una herramienta esencial para apoyar una mejor respuesta por parte de los gobiernos a las emergencias sanitarias.<\/p>\n\n    <div class=\"xs_social_share_widget xs_share_url after_content \t\tmain_content  wslu-style-1 wslu-share-box-shaped wslu-fill-colored wslu-none wslu-share-horizontal wslu-theme-font-no wslu-main_content\">\n\n\t\t\n        <ul>\n\t\t\t        <\/ul>\n    <\/div>","protected":false},"excerpt":{"rendered":"<p>Con m\u00e1s de 100 participantes representando a las agencias reguladoras, la industria y la academia de pr\u00e1cticamente todos los pa\u00edses de las Am\u00e9ricas, se celebr\u00f3 virtualmente, del 22 al 24 de febrero, la DIA Latin American Regulatory Conference (Conferencia Regulatoria Latinoamericana de la Asociaci\u00f3n de Informaci\u00f3n sobre Medicamentos -DIA). Durante la Conferencia expertos \u2013 con [&hellip;]<\/p>","protected":false},"author":24,"featured_media":1651,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"enableOnePageScrollInPage":false,"onePageScrollCss":"","onePageScrollSpeed":1000,"onePageScrollAnimation":"easeInOutQuad","onePageScrollShowDotNavigation":true,"onePageScrollNavigation":"scaleUp","onePageScrollNavigationPosition":"right","onePageScrollNavigationHorizontal":[],"onePageScrollNavigationVertical":[],"onePageScrollNavigationSpacing":[],"onePageScrollNavigationColor":"#00ff0d","onePageScrollNavigationColorHover":"#00ff0d","onePageScrollNavigationColorActive":"#00ff0d","onePageScrollNavigationIcon":[],"onePageScrollNavigationWidth":[],"onePageScrollNavigationWidthHover":[],"onePageScrollNavigationWidthActive":[],"onePageScrollNavigationHeight":[],"onePageScrollNavigationHeightHover":[],"onePageScrollNavigationHeightActive":[],"onePageScrollNavigationBorder":[],"onePageScrollNavigationBorderHover":[],"onePageScrollNavigationBorderActive":[],"onePageScrollNavigationBorderRadius":[],"onePageScrollNavigationBorderRadiusHover":[],"onePageScrollNavigationBorderRadiusActive":[],"onePageScrollNavigationTooltipTypography":[],"onePageScrollNavigationTooltipColor":"#ffffff","onePageScrollNavigationTooltipColorHover":"","onePageScrollNavigationTooltipBgColor":"#00ff0d","onePageScrollNavigationTooltipBgColorHover":"","onePageScrollNavigationTooltipPadding":[],"onePageScrollNavigationTooltipPaddingHover":[],"onePageScrollNavigationTooltipBorderRadius":[],"onePageScrollNavigationTooltipBorderRadiusHover":[],"pageSettingsCustomCss":"","footnotes":""},"categories":[6],"tags":[],"class_list":["post-1648","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-publicaciones"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.7 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FIFARMA participa en la conferencia regulatoria latinoamericana 2021 - FIFARMA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fifarma.org\/en\/fifarma-participa-en-la-conferencia-regulatoria-latinoamericana-2021\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FIFARMA participa en la conferencia regulatoria latinoamericana 2021\" \/>\n<meta property=\"og:description\" content=\"Con m\u00e1s de 100 participantes representando a las agencias reguladoras, la industria y la academia de pr\u00e1cticamente todos los pa\u00edses de las Am\u00e9ricas, se celebr\u00f3 virtualmente, del 22 al 24 de febrero, la DIA Latin American Regulatory Conference (Conferencia Regulatoria Latinoamericana de la Asociaci\u00f3n de Informaci\u00f3n sobre Medicamentos -DIA). 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