{"id":9682,"date":"2026-03-19T16:44:56","date_gmt":"2026-03-19T08:44:56","guid":{"rendered":"https:\/\/regask.com\/?p=9682"},"modified":"2026-03-19T16:46:03","modified_gmt":"2026-03-19T08:46:03","slug":"la-fda-americaine-lance-aems-une-plateforme-unifiee-pour-le-signalement-des-evenements-indesirables-et-la-surveillance-de-la-securite","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/u-s-fda-introduces-aems-a-unified-platform-for-adverse-event-reporting-and-safety-surveillance\/","title":{"rendered":"La FDA am\u00e9ricaine lance AEMS\u00a0: une plateforme unifi\u00e9e pour la gestion des effets ind\u00e9sirables\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Sur <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">11 mars 2026<\/span><\/span><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">, le\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Administration am\u00e9ricaine des aliments et des m\u00e9dicaments (FDA)<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">\u00a0introduit le<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Syst\u00e8me de surveillance des \u00e9v\u00e9nements ind\u00e9sirables (AEMS)<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\"><strong>,<\/strong> une plateforme centralis\u00e9e con\u00e7ue pour rationaliser le signalement des \u00e9v\u00e9nements ind\u00e9sirables dans tous les\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Cat\u00e9gories de produits r\u00e9glement\u00e9s par la FDA<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\"><strong>.<\/strong> Le syst\u00e8me a des r\u00e9percussions sur les parties prenantes impliqu\u00e9es dans\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">pharmacovigilance, notification des effets ind\u00e9sirables et conformit\u00e9 r\u00e9glementaire<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\"><strong>,<\/strong> couvrant des secteurs tels que les produits m\u00e9dicaux, les vaccins, les dispositifs m\u00e9dicaux, le tabac, l&#039;alimentation, les cosm\u00e9tiques et les m\u00e9dicaments v\u00e9t\u00e9rinaires.<\/span><\/span><span class=\"EOP SCXW130125533 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-362777033\">\n\n\t<div id=\"col-1922265223\" 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-1106189802\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1106189802 {\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-1925594044\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1925594044 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Le nouveau lancement\u00a0<\/span><b><span data-contrast=\"auto\">AEMS<\/span><\/b><span data-contrast=\"auto\">\u00a0remplace plusieurs syst\u00e8mes de reporting h\u00e9rit\u00e9s par un\u00a0<\/span><b><span data-contrast=\"auto\">plateforme unique et unifi\u00e9e<\/span><\/b><span data-contrast=\"auto\">, permettant des protocoles de soumission standardis\u00e9s et une meilleure coh\u00e9rence des donn\u00e9es entre les cat\u00e9gories de produits. Il introduit\u00a0<\/span><b><span data-contrast=\"auto\">flux de travail avanc\u00e9s de traitement des cas<\/span><\/b><span data-contrast=\"auto\">\u00a0soutenu par\u00a0<\/span><b><span data-contrast=\"auto\">outils de r\u00e9daction et de num\u00e9risation bas\u00e9s sur l&#039;intelligence artificielle<\/span><\/b><span data-contrast=\"auto\">, am\u00e9liorant ainsi l&#039;efficacit\u00e9 et la qualit\u00e9 des rapports soumis.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Le syst\u00e8me se renforce \u00e9galement\u00a0<\/span><b><span data-contrast=\"auto\">capacit\u00e9s de surveillance interproduits<\/span><\/b><span data-contrast=\"auto\">\u00a0Gr\u00e2ce \u00e0 des analyses am\u00e9lior\u00e9es, les organismes de r\u00e9glementation et les parties prenantes peuvent identifier des tendances et des signaux communs \u00e0 diff\u00e9rents types de produits. Outre le signalement des effets ind\u00e9sirables, AEMS prend en charge\u00a0<\/span><b><span data-contrast=\"auto\">plaintes de consommateurs, signalements de manquements r\u00e9glementaires et d\u00e9clarations de lanceurs d&#039;alerte<\/span><\/b><span data-contrast=\"auto\">, \u00e9largissant ainsi le champ d&#039;application de la surveillance de la s\u00e9curit\u00e9.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Une caract\u00e9ristique essentielle du syst\u00e8me est le\u00a0<\/span><b><span data-contrast=\"auto\">Tableau de bord public AEMS<\/span><\/b><span data-contrast=\"auto\">, qui fournit aux parties prenantes\u00a0<\/span><b><span data-contrast=\"auto\">acc\u00e8s consultable aux \u00e9v\u00e9nements ind\u00e9sirables signal\u00e9s<\/span><\/b><span data-contrast=\"auto\">. Bien que cela favorise la transparence et la facilit\u00e9 d&#039;utilisation, la FDA souligne que les donn\u00e9es rapport\u00e9es\u00a0<\/span><b><span data-contrast=\"auto\">peut contenir des doublons ou des informations incompl\u00e8tes<\/span><\/b><span data-contrast=\"auto\">\u00a0et\u00a0<\/span><b><span data-contrast=\"auto\">ne permet pas d&#039;\u00e9tablir de lien de causalit\u00e9, de taux d&#039;incidence ou de profils de s\u00e9curit\u00e9 d\u00e9finitifs du produit<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1922265223 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-150641874\" 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-613463860\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-613463860 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">La mise en \u0153uvre de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">AEMS<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0am\u00e9liore\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\"><strong>efficacit\u00e9 r\u00e9glementaire et donn\u00e9es<\/strong> <strong>int\u00e9gration<\/strong><\/span><\/span><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0par\u00a0<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">consolidation<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0int\u00e9grer des syst\u00e8mes de reporting disparates dans un cadre unifi\u00e9. L&#039;utilisation de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">Outils bas\u00e9s sur l&#039;IA et flux de travail standardis\u00e9s<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0il contribue \u00e0 am\u00e9liorer la qualit\u00e9 des donn\u00e9es et la d\u00e9tection des signaux, tandis que le tableau de bord public s&#039;inscrit dans des objectifs plus larges.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">transparence et accessibilit\u00e9 num\u00e9rique<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\"><strong>.<\/strong> Globalement, le syst\u00e8me est con\u00e7u pour renforcer la surveillance de la s\u00e9curit\u00e9 tout au long du cycle de vie, tandis que\u00a0<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">maintenance<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">faible charge administrative<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0pour les parties prenantes.<\/span><\/span><span class=\"EOP SCXW91408954 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-150641874 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1191316174\" 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>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-1554010003\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1554010003 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour concerne les professionnels du secteur <strong>\u00e9quipes des affaires r\u00e9glementaires, de la pharmacovigilance, de l&#039;assurance qualit\u00e9, de la conformit\u00e9 et des technologies de l&#039;information,<\/strong> en particulier ceux qui sont responsables de <strong>d\u00e9claration des \u00e9v\u00e9nements ind\u00e9sirables, gestion des donn\u00e9es de s\u00e9curit\u00e9 et soumissions r\u00e9glementaires<\/strong> dans tous les secteurs r\u00e9glement\u00e9s par la FDA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1191316174 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-37660478\" 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-676433841\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-676433841 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les organisations devraient\u00a0<\/span><b><span data-contrast=\"auto\">examiner les fonctionnalit\u00e9s de la plateforme AEMS<\/span><\/b><span data-contrast=\"auto\">\u00a0et \u00e9valuer la compatibilit\u00e9 des flux de travail de reporting actuels avec le nouveau syst\u00e8me consolid\u00e9. Les \u00e9quipes responsables de\u00a0<\/span><b><span data-contrast=\"auto\">Signalement des \u00e9v\u00e9nements ind\u00e9sirables et gestion des plaintes<\/span><\/b><span data-contrast=\"auto\">\u00a0sont encourag\u00e9s \u00e0 se familiariser avec\u00a0<\/span><b><span data-contrast=\"auto\">fonctionnalit\u00e9s de requ\u00eate du tableau de bord public<\/span><\/b><span data-contrast=\"auto\">\u00a0et suivre les mises \u00e0 jour en cours. Au fil du temps, les parties prenantes pourraient envisager\u00a0<\/span><b><span data-contrast=\"auto\">adaptation des processus internes de gestion des donn\u00e9es et de surveillance des signaux<\/span><\/b><span data-contrast=\"auto\">\u00a0pour tirer parti d&#039;un meilleur acc\u00e8s aux informations sur la s\u00e9curit\u00e9 des produits.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00c0 mesure que les syst\u00e8mes r\u00e9glementaires continuent d&#039;\u00e9voluer vers\u00a0<\/span><b><span data-contrast=\"auto\">plateformes centralis\u00e9es et dot\u00e9es d&#039;IA<\/span><\/b><span data-contrast=\"auto\">, des solutions comme\u00a0<\/span><a href=\"http:\/\/regask.com\/fr\/\"><b><span data-contrast=\"auto\">RegASK<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0peut aider les organisations \u00e0 garder une longueur d&#039;avance sur ces changements.\u00a0<a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a>\u00a0est 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,\u00a0<a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a>\u00a0Elle 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.<strong><a href=\"http:\/\/regask.com\/fr\/\"> En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9servez une d\u00e9mo maintenant.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-37660478 > .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-1369885414\">\n\n\t<div id=\"col-429970788\" 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-1575795742\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1575795742 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW179543514 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW179543514 BCX0\">Qu\u2019est-ce que le syst\u00e8me de surveillance des \u00e9v\u00e9nements ind\u00e9sirables de la FDA (AEMS)\u00a0?<\/span><\/span><span class=\"EOP SCXW179543514 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1386310125\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1386310125 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le <strong>AEMS<\/strong> est une plateforme centralis\u00e9e lanc\u00e9e par la FDA pour g\u00e9rer le signalement des effets ind\u00e9sirables dans toutes les cat\u00e9gories de produits r\u00e9glement\u00e9es par la FDA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-429970788 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-179219372\" 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><span class=\"TextRun MacChromeBold SCXW250270229 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250270229 BCX0\">Quels types de rapports AEMS traite-t-il\u00a0?<\/span><\/span><span class=\"EOP SCXW250270229 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1935776822\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1935776822 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le syst\u00e8me prend en charge <strong>Rapports d&#039;\u00e9v\u00e9nements ind\u00e9sirables, plaintes de consommateurs, rapports de manquements \u00e0 la r\u00e9glementation et signalements de lanceurs d&#039;alerte. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-179219372 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-785837325\" 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><span class=\"TextRun MacChromeBold SCXW232842177 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232842177 BCX0\">Les donn\u00e9es AEMS peuvent-elles \u00eatre utilis\u00e9es pour\u00a0<\/span><span class=\"NormalTextRun SCXW232842177 BCX0\">d\u00e9terminer<\/span><span class=\"NormalTextRun SCXW232842177 BCX0\">\u00a0S\u00e9curit\u00e9 du produit ou causalit\u00e9 ?<\/span><\/span><span class=\"EOP SCXW232842177 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1336167841\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1336167841 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Non. La FDA indique que les donn\u00e9es AEMS <strong>ne permet pas d&#039;\u00e9tablir de lien de causalit\u00e9, de taux d&#039;incidence ou de profils de s\u00e9curit\u00e9 d\u00e9finitifs.,<\/strong> et peuvent inclure des rapports incomplets ou en double.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-785837325 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-518646718\" 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><span class=\"TextRun MacChromeBold SCXW252578696 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW252578696 BCX0\">Comment peut-on\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW252578696 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW252578696 BCX0\">\u00a0aider les organisations \u00e0 s&#039;adapter \u00e0 l&#039;AEMS ?<\/span><\/span><span class=\"EOP SCXW252578696 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1332191810\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1332191810 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW213849445 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><strong><a href=\"http:\/\/regask.com\/fr\/\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW213849445 BCX0\">RegASK<\/span><\/a><\/strong><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0aide les organisations\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213849445 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213849445 BCX0\">moniteur<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0mises \u00e0 jour r\u00e9glementaires, rationalisation des processus de conformit\u00e9 et\u00a0<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">effet de levier<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0Informations g\u00e9n\u00e9r\u00e9es par l&#039;IA<\/span><\/span><\/strong><span class=\"TextRun SCXW213849445 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213849445 BCX0\"><strong>,<\/strong> permettre une adaptation plus efficace aux syst\u00e8mes comme les AEMS et am\u00e9liorer les pratiques de gestion des donn\u00e9es de s\u00e9curit\u00e9.<\/span><\/span><span class=\"EOP SCXW213849445 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-518646718 > .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 11 March 2026, the\u00a0U.S. Food and Drug Administration (FDA)\u00a0introduced theAdverse Event Monitoring System (AEMS), a centralized platform designed to streamline adverse event reporting across all\u00a0FDA-regulated product categories. The system impacts stakeholders involved in\u00a0pharmacovigilance, safety reporting, and regulatory compliance, covering sectors such as medical products, vaccines, medical devices, tobacco, food, cosmetics, and veterinary medicines.\u00a0<\/p>","protected":false},"author":43,"featured_media":9684,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,34],"tags":[],"class_list":["post-9682","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-food-beverage-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>U.S. FDA Introduces AEMS: Revolutionizing Reporting<\/title>\n<meta name=\"description\" content=\"Learn about the U.S. FDA&#039;s new AEMS 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