{"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-et-sante-canada-annoncent-un-symposium-conjoint-sur-la-bioequivalence-et-la-pharmacovigilance-des-bpc","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-mhra-and-health-canada-announce-joint-symposium-on-gcp-bioequivalence-and-pharmacovigilance\/","title":{"rendered":"La FDA, la MHRA et Sant\u00e9 Canada annoncent un symposium conjoint sur\u2026"},"content":{"rendered":"<p>Sur <strong>10 mars 2026<\/strong>, le <strong>Administration am\u00e9ricaine des aliments et des m\u00e9dicaments (FDA)<\/strong>, en collaboration avec <strong>Agence de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9 (MHRA)<\/strong> et <strong>Sant\u00e9 Canada<\/strong>, a \u00e9mis un rappel pour une r\u00e9union conjointe <strong>symposium hybride<\/strong> ax\u00e9 sur <strong>Bonnes pratiques cliniques (BPC)<\/strong>, <strong>bio\u00e9quivalence (BE)<\/strong>, et <strong>Bonnes pratiques de pharmacovigilance (BPP)<\/strong>. Pr\u00e9vu pour <strong>2-4 juin 2026<\/strong>, L&#039;\u00e9v\u00e9nement abordera les points suivants : <strong>\u00e9volution des attentes r\u00e9glementaires<\/strong> et la mise en \u0153uvre de <strong>ICH E6(R3)<\/strong> \u00e0 travers l&#039;Am\u00e9rique du Nord et le Royaume-Uni.<\/p>\n<div class=\"row\"  id=\"row-1274349797\">\n\n\t<div id=\"col-585059679\" 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-1869814920\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1869814920 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-333616383\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-333616383 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le symposium r\u00e9unira des experts en r\u00e9glementation pour discuter <strong>exigences actuelles et \u00e9mergentes<\/strong> pour <strong>essais cliniques<\/strong>, <strong>\u00e9tudes de bio\u00e9quivalence<\/strong>, et <strong>pratiques de pharmacovigilance<\/strong>. Un th\u00e8me central sera la mise en \u0153uvre de <strong>ICH E6(R3)<\/strong>, la directive r\u00e9vis\u00e9e mettant l&#039;accent sur un <strong>une approche ax\u00e9e sur la qualit\u00e9 et proportionn\u00e9e aux risques<\/strong> \u00e0 la conduite des essais cliniques.<\/p>\n<p>Les s\u00e9ances exploreront <strong>Principes de qualit\u00e9 par la conception<\/strong> en recherche clinique et \u00e9tudes de bio\u00e9quivalence, en soulignant comment ces approches peuvent \u00eatre int\u00e9gr\u00e9es \u00e0 la planification et \u00e0 la r\u00e9alisation des essais. De plus, des mises \u00e0 jour sur <strong>Exigences BVP<\/strong> fournira des orientations aux parties prenantes responsables de <strong>surveillance de la s\u00e9curit\u00e9 des patients<\/strong>.<\/p>\n<p>Les autorit\u00e9s r\u00e9glementaires de la FDA, de la MHRA et de Sant\u00e9 Canada partageront \u00e9galement leurs points de vue sur <strong>d\u00e9veloppement de lignes directrices<\/strong>, <strong>\u00e9tat de pr\u00e9paration \u00e0 l&#039;inspection<\/strong>, et <strong>efforts d&#039;harmonisation internationale<\/strong>, offrant une perspective interr\u00e9gionale sur les attentes en mati\u00e8re de conformit\u00e9.<\/p>\n<p>L&#039;\u00e9v\u00e9nement est ouvert aux inscriptions et se d\u00e9roulera dans un <strong>format hybride<\/strong>, avec des informations compl\u00e9mentaires disponibles aupr\u00e8s de la FDA <strong>Aide aux petites entreprises et \u00e0 l&#039;industrie<\/strong> cha\u00eenes.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-585059679 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1738548277\" 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>Date de l&#039;\u00e9v\u00e9nement<\/h2>\n\t<div id=\"gap-390775623\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-390775623 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le symposium aura lieu \u00e0 partir de <strong>Du 2 au 4 juin 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1738548277 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-90094327\" 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>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-1588361250\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1588361250 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ce symposium offre <strong>clart\u00e9 r\u00e9glementaire essentielle<\/strong> sur l&#039;adoption de <strong>ICH E6(R3)<\/strong> et ses implications pour <strong>cadres de qualit\u00e9, de surveillance de la s\u00e9curit\u00e9 et de conformit\u00e9 des essais cliniques<\/strong>. Il prend en charge <strong>alignement global<\/strong> aupr\u00e8s des autorit\u00e9s r\u00e9glementaires et promeut <strong>approches efficaces et fond\u00e9es sur les risques<\/strong> au d\u00e9veloppement des m\u00e9dicaments et \u00e0 la surveillance post-commercialisation.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-90094327 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1254545806\" 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>Qui est concern\u00e9 ?<\/h2>\n\t<div id=\"gap-1167661085\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1167661085 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>Affaires r\u00e9glementaires<\/strong>, <strong>Assurance qualit\u00e9<\/strong>, <strong>S\u00e9curit\u00e9 des patients<\/strong>, <strong>Juridique\/Conformit\u00e9<\/strong>, <strong>R&amp;D<\/strong>, et <strong>\u00e9quipes commerciales<\/strong> impliqu\u00e9 dans <strong>d\u00e9veloppement clinique, \u00e9tudes de bio\u00e9quivalence et activit\u00e9s de pharmacovigilance<\/strong> aupr\u00e8s des entreprises pharmaceutiques op\u00e9rant en Am\u00e9rique du Nord et au Royaume-Uni.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1254545806 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1377346433\" 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>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-513258282\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-513258282 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient <strong>actes du symposium de suivi<\/strong> ou pr\u00e9voir de <strong>examen des documents post-\u00e9v\u00e9nement<\/strong> \u00e9valuer comment <strong>Mise en \u0153uvre de la norme ICH E6(R3)<\/strong> et les nouvelles exigences r\u00e9glementaires peuvent avoir une incidence sur les programmes cliniques en cours ou futurs. Les \u00e9quipes peuvent \u00e9galement envisager <strong>assister \u00e0 l&#039;\u00e9v\u00e9nement<\/strong> pour obtenir des informations directes sur l&#039;\u00e9volution des priorit\u00e9s en mati\u00e8re de conformit\u00e9 et d&#039;inspection.<\/p>\n<p>Face \u00e0 l&#039;\u00e9volution constante des exigences r\u00e9glementaires en mati\u00e8re de recherche clinique et de surveillance de la s\u00e9curit\u00e9 \u00e0 l&#039;\u00e9chelle mondiale, il est essentiel de se tenir inform\u00e9 des lignes directrices harmonis\u00e9es afin de garantir la conformit\u00e9 et la capacit\u00e9 op\u00e9rationnelle.<\/p>\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentique, qui permet aux organisations internationales des secteurs fortement r\u00e9glement\u00e9s, tels que les produits de consommation et les sciences de la vie, d&#039;anticiper les complexit\u00e9s r\u00e9glementaires. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9server une d\u00e9mo<\/a> maintenant.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1377346433 > .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-1988682114\">\n\n\t<div id=\"col-924710556\" 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>FAQ<\/h3>\n\t<div id=\"gap-34494516\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-34494516 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Quel est l\u2019objectif du symposium FDA-MHRA-Sant\u00e9 Canada\u00a0?<\/h4>\n\t<div id=\"gap-873584591\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-873584591 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le symposium fournit des mises \u00e0 jour sur <strong>attentes r\u00e9glementaires en mati\u00e8re de BPC, de bio\u00e9quivalence et de pharmacovigilance<\/strong>, en mettant l&#039;accent sur <strong>Mise en \u0153uvre de la norme ICH E6(R3)<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-924710556 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1687308833\" 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>Quand aura lieu le symposium ?<\/h4>\n\t<div id=\"gap-2043266523\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2043266523 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Il est pr\u00e9vu pour <strong>2-4 juin 2026<\/strong>, et se tiendra dans un <strong>format hybride<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1687308833 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-285388550\" 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>Quels sujets seront abord\u00e9s lors de cet \u00e9v\u00e9nement ?<\/h4>\n\t<div id=\"gap-1398842264\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1398842264 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les s\u00e9ances aborderont les points suivants : <strong>qualit\u00e9 par conception dans les essais cliniques<\/strong>, <strong>\u00e9tudes de bio\u00e9quivalence<\/strong>, <strong>Mises \u00e0 jour GVP<\/strong>, et <strong>efforts d&#039;harmonisation r\u00e9glementaire internationale<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-285388550 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-68488509\" 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>Comment le programme RegASK peut-il aider les \u00e9quipes \u00e0 se pr\u00e9parer \u00e0 la norme ICH E6(R3) et aux exigences GCP en constante \u00e9volution\u00a0?<\/h4>\n\t<div id=\"gap-805610965\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-805610965 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\">RegASK <\/a>aide les organisations <strong>Suivre les mises \u00e0 jour r\u00e9glementaires<\/strong>, aligner <strong>Processus cliniques et de s\u00e9curit\u00e9 avec orientations mondiales<\/strong>, et rationaliser <strong>flux de travail de conformit\u00e9<\/strong>, contribuant ainsi \u00e0 la pr\u00e9paration aux normes \u00e9volutives en mati\u00e8re de BPC et de pharmacovigilance.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-68488509 > .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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