{"id":9712,"date":"2026-03-25T16:21:55","date_gmt":"2026-03-25T08:21:55","guid":{"rendered":"https:\/\/regask.com\/?p=9712"},"modified":"2026-03-26T14:34:30","modified_gmt":"2026-03-26T06:34:30","slug":"la-fda-la-mhra-y-health-canada-anuncian-un-simposio-conjunto-sobre-bioequivalencia-de-buenas-practicas-clinicas-y-farmacovigilancia","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-mhra-and-health-canada-announce-joint-symposium-on-gcp-bioequivalence-and-pharmacovigilance\/","title":{"rendered":"La FDA, la MHRA y Health Canada anuncian un simposio conjunto sobre\u2026"},"content":{"rendered":"<p>En <strong>10 de marzo de 2026<\/strong>, el <strong>Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/strong>, en colaboraci\u00f3n con el <strong>Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA)<\/strong> y <strong>Salud Canad\u00e1<\/strong>, emiti\u00f3 un recordatorio para una reuni\u00f3n conjunta <strong>simposio h\u00edbrido<\/strong> centrado en <strong>Buenas Pr\u00e1cticas Cl\u00ednicas (BPC)<\/strong>, <strong>bioequivalencia (BE)<\/strong>, y <strong>Buenas Pr\u00e1cticas de Farmacovigilancia (BPF)<\/strong>. Programado para <strong>Del 2 al 4 de junio de 2026<\/strong>, El evento abordar\u00e1 <strong>expectativas regulatorias en evoluci\u00f3n<\/strong> y la implementaci\u00f3n de <strong>ICH E6(R3)<\/strong> en toda Norteam\u00e9rica y el Reino Unido.<\/p>\n<div class=\"row\"  id=\"row-96157862\">\n\n\t<div id=\"col-1914549592\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1417344141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1417344141 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1967101773\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1967101773 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El simposio reunir\u00e1 a expertos en regulaci\u00f3n para debatir <strong>Requisitos actuales y emergentes<\/strong> para <strong>ensayos cl\u00ednicos<\/strong>, <strong>estudios de bioequivalencia<\/strong>, y <strong>pr\u00e1cticas de farmacovigilancia<\/strong>. Un tema central ser\u00e1 la implementaci\u00f3n de <strong>ICH E6(R3)<\/strong>, la directriz revisada enfatiza una <strong>Enfoque centrado en la calidad y proporcional al riesgo.<\/strong> para la realizaci\u00f3n de ensayos cl\u00ednicos.<\/p>\n<p>Las sesiones explorar\u00e1n <strong>Principios de calidad por dise\u00f1o<\/strong> en la investigaci\u00f3n cl\u00ednica y los estudios de bioequivalencia, destacando c\u00f3mo estos enfoques pueden integrarse en la planificaci\u00f3n y ejecuci\u00f3n de los ensayos. Adem\u00e1s, actualizaciones sobre <strong>Requisitos de GVP<\/strong> proporcionar\u00e1 orientaci\u00f3n a las partes interesadas responsables de <strong>monitorizaci\u00f3n de la seguridad del paciente<\/strong>.<\/p>\n<p>Las autoridades reguladoras de la FDA, la MHRA y Health Canada tambi\u00e9n compartir\u00e1n informaci\u00f3n sobre <strong>desarrollo de la orientaci\u00f3n<\/strong>, <strong>preparaci\u00f3n para la inspecci\u00f3n<\/strong>, y <strong>esfuerzos de armonizaci\u00f3n internacional<\/strong>, ofreciendo una perspectiva interregional sobre las expectativas de cumplimiento.<\/p>\n<p>El evento est\u00e1 abierto para inscripciones y se llevar\u00e1 a cabo en un <strong>formato h\u00edbrido<\/strong>, con m\u00e1s detalles disponibles a trav\u00e9s de la FDA <strong>Asistencia para peque\u00f1as empresas e industrias<\/strong> canales.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1914549592 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-594534761\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Fecha del evento<\/h2>\n\t<div id=\"gap-358396787\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-358396787 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El simposio tendr\u00e1 lugar a partir de <strong>Del 2 al 4 de junio de 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-594534761 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1514727844\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-1392531115\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1392531115 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Este simposio proporciona <strong>claridad regulatoria fundamental<\/strong> sobre la adopci\u00f3n de <strong>ICH E6(R3)<\/strong> y sus implicaciones para <strong>Marcos de calidad, monitorizaci\u00f3n de la seguridad y cumplimiento de los ensayos cl\u00ednicos<\/strong>. Es compatible <strong>alineaci\u00f3n global<\/strong> en todas las autoridades reguladoras y promueve <strong>enfoques eficientes basados en el riesgo<\/strong> al desarrollo de f\u00e1rmacos y a la vigilancia posterior a la comercializaci\u00f3n.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1514727844 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1345188892\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>A qui\u00e9n afecta esto<\/h2>\n\t<div id=\"gap-790003511\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-790003511 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Asuntos regulatorios<\/strong>, <strong>Seguro de calidad<\/strong>, <strong>Seguridad del paciente<\/strong>, <strong>Asuntos legales\/Cumplimiento normativo<\/strong>, <strong>I+D<\/strong>, y <strong>Equipos comerciales<\/strong> involucrado en <strong>desarrollo cl\u00ednico, estudios de bioequivalencia y actividades de farmacovigilancia<\/strong> en todas las organizaciones farmac\u00e9uticas que operan en Norteam\u00e9rica y el Reino Unido.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1345188892 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-101749073\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1655077514\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1655077514 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deber\u00edan <strong>Actas del simposio de seguimiento<\/strong> o planear <strong>revisar los materiales posteriores al evento<\/strong> evaluar c\u00f3mo <strong>Implementaci\u00f3n de ICH E6(R3)<\/strong> y las expectativas regulatorias actualizadas pueden afectar los programas cl\u00ednicos en curso o futuros. Los equipos tambi\u00e9n pueden considerar <strong>asistir al evento<\/strong> para obtener informaci\u00f3n directa sobre la evoluci\u00f3n de las prioridades en materia de cumplimiento normativo e inspecci\u00f3n.<\/p>\n<p>A medida que las expectativas regulatorias en materia de investigaci\u00f3n cl\u00ednica y vigilancia de la seguridad contin\u00faan evolucionando a nivel mundial, mantenerse informado sobre las directrices armonizadas es esencial para garantizar el cumplimiento normativo y la preparaci\u00f3n operativa.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector, <a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reservar una demostraci\u00f3n<\/a> ahora.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-101749073 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1475411047\">\n\n\t<div id=\"col-1806789874\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-962713470\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-962713470 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfCu\u00e1l es el prop\u00f3sito del simposio FDA-MHRA-Health Canada?<\/h4>\n\t<div id=\"gap-1861482842\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1861482842 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El simposio ofrece actualizaciones sobre <strong>Expectativas regulatorias para las Buenas Pr\u00e1cticas Cl\u00ednicas (BPC), la bioequivalencia y la farmacovigilancia.<\/strong>, con un enfoque en <strong>Implementaci\u00f3n de ICH E6(R3)<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1806789874 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1331973641\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfCu\u00e1ndo tendr\u00e1 lugar el simposio?<\/h4>\n\t<div id=\"gap-1002897071\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1002897071 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Est\u00e1 programado para <strong>Del 2 al 4 de junio de 2026<\/strong>, y se celebrar\u00e1 en un <strong>formato h\u00edbrido<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1331973641 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-622573363\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfQu\u00e9 temas se tratar\u00e1n durante el evento?<\/h4>\n\t<div id=\"gap-1935592615\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1935592615 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las sesiones abordar\u00e1n <strong>calidad desde el dise\u00f1o en ensayos cl\u00ednicos<\/strong>, <strong>estudios de bioequivalencia<\/strong>, <strong>Actualizaciones de GVP<\/strong>, y <strong>esfuerzos de armonizaci\u00f3n regulatoria internacional<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-622573363 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-810881142\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfC\u00f3mo puede RegASK ayudar a los equipos que se preparan para la gu\u00eda ICH E6(R3) y los requisitos en constante evoluci\u00f3n de las Buenas Pr\u00e1cticas Cl\u00ednicas (BPC)?<\/h4>\n\t<div id=\"gap-1279975907\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1279975907 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\">RegASK <\/a>ayuda a las organizaciones <strong>Seguimiento de las actualizaciones regulatorias<\/strong>, alinear <strong>procesos cl\u00ednicos y de seguridad con orientaci\u00f3n global<\/strong>, y simplificar <strong>flujos de trabajo de cumplimiento<\/strong>, lo que respalda la preparaci\u00f3n para la evoluci\u00f3n de las normas de buenas pr\u00e1cticas cl\u00ednicas (BPC) y de farmacovigilancia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-810881142 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On March 10, 2026, the U.S. Food and Drug Administration (FDA), in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada, issued a reminder for a joint hybrid symposium focused on Good Clinical Practice (GCP), bioequivalence (BE), and Good Pharmacovigilance Practice (GVP). Scheduled for June 2\u20134, 2026, the event will address&#8230;<\/p>","protected":false},"author":32,"featured_media":9713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[530,33,35],"tags":[],"class_list":["post-9712","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-north-america","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA MHRA and Health Canada Announce a Focus on GCP Practices<\/title>\n<meta name=\"description\" content=\"Learn about the upcoming symposium focused on GCP bioequivalence and pharmacovigilance hosted by the FDA, MHRA, and Health Canada.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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