{"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":"die-us-amerikanische-arzneimittelbehorde-fda-fuhrt-aems-ein-eine-einheitliche-plattform-fur-die-meldung-unerwunschter-ereignisse-und-die-sicherheitsuberwachung","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/u-s-fda-introduces-aems-a-unified-platform-for-adverse-event-reporting-and-safety-surveillance\/","title":{"rendered":"Die US-amerikanische Arzneimittelbeh\u00f6rde FDA stellt AEMS vor: Eine einheitliche Plattform f\u00fcr unerw\u00fcnschte Ereignisse\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">An <\/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. M\u00e4rz 2026<\/span><\/span><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">, Die\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">US-amerikanische Food and Drug Administration (FDA)<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">\u00a0stellte die<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">System zur \u00dcberwachung unerw\u00fcnschter Ereignisse (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> eine zentrale Plattform, die die Meldung unerw\u00fcnschter Ereignisse in allen Bereichen vereinfachen soll\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\">FDA-regulierte Produktkategorien<\/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> Das System hat Auswirkungen auf die beteiligten Akteure\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\">Pharmakovigilanz, Sicherheitsberichterstattung und Einhaltung gesetzlicher Vorschriften<\/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> Die Bereiche umfassen unter anderem Medizinprodukte, Impfstoffe, Medizinprodukte, Tabakwaren, Lebensmittel, Kosmetika und Tierarzneimittel.<\/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-1758858814\">\n\n\t<div id=\"col-885146095\" 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-970631119\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-970631119 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-1164142802\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1164142802 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die neu gestartete\u00a0<\/span><b><span data-contrast=\"auto\">AEMS<\/span><\/b><span data-contrast=\"auto\">\u00a0ersetzt mehrere veraltete Berichtssysteme durch ein\u00a0<\/span><b><span data-contrast=\"auto\">einheitliche Plattform<\/span><\/b><span data-contrast=\"auto\">, Dadurch werden standardisierte \u00dcbermittlungsprotokolle und eine verbesserte Datenkonsistenz \u00fcber alle Produktkategorien hinweg erm\u00f6glicht. Es f\u00fchrt ein\u00a0<\/span><b><span data-contrast=\"auto\">fortgeschrittene Arbeitsabl\u00e4ufe zur Fallbearbeitung<\/span><\/b><span data-contrast=\"auto\">\u00a0unterst\u00fctzt von\u00a0<\/span><b><span data-contrast=\"auto\">KI-basierte Schw\u00e4rzungs- und Digitalisierungswerkzeuge<\/span><\/b><span data-contrast=\"auto\">, wodurch die Effizienz und Qualit\u00e4t der eingereichten Berichte verbessert werden.<\/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\">Das System st\u00e4rkt auch\u00a0<\/span><b><span data-contrast=\"auto\">produkt\u00fcbergreifende \u00dcberwachungsf\u00e4higkeiten<\/span><\/b><span data-contrast=\"auto\">\u00a0durch verbesserte Analysen, die es Aufsichtsbeh\u00f6rden und Interessengruppen erm\u00f6glichen, Muster und Signale \u00fcber verschiedene Produkttypen hinweg zu erkennen. Zus\u00e4tzlich zur Meldung unerw\u00fcnschter Ereignisse unterst\u00fctzt AEMS\u00a0<\/span><b><span data-contrast=\"auto\">Verbraucherbeschwerden, Meldungen \u00fcber Fehlverhalten von Aufsichtsbeh\u00f6rden und Hinweisgebermeldungen<\/span><\/b><span data-contrast=\"auto\">, wodurch der Umfang der Sicherheits\u00fcberwachung erweitert wird.<\/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\">Ein Hauptmerkmal des Systems ist die\u00a0<\/span><b><span data-contrast=\"auto\">\u00d6ffentliches AEMS-Dashboard<\/span><\/b><span data-contrast=\"auto\">, das den Beteiligten Folgendes bietet\u00a0<\/span><b><span data-contrast=\"auto\">Suchbarer Zugriff auf gemeldete unerw\u00fcnschte Ereignisse<\/span><\/b><span data-contrast=\"auto\">. Dies f\u00f6rdert zwar Transparenz und Benutzerfreundlichkeit, die FDA betont jedoch, dass die gemeldeten Daten\u00a0<\/span><b><span data-contrast=\"auto\">kann Duplikate oder unvollst\u00e4ndige Informationen enthalten<\/span><\/b><span data-contrast=\"auto\">\u00a0Und\u00a0<\/span><b><span data-contrast=\"auto\">Es werden keine Kausalzusammenh\u00e4nge, Inzidenzraten oder endg\u00fcltige Produktsicherheitsprofile ermittelt.<\/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-885146095 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1784422647\" 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>Warum es wichtig ist<\/h2>\n\t<div id=\"gap-1563160620\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1563160620 {\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\">Die Umsetzung von\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\">\u00a0verbessert\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>Regulierungseffizienz und Daten<\/strong> <strong>Integration<\/strong><\/span><\/span><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0von\u00a0<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">Konsolidierung<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0unterschiedliche Berichtssysteme in einen einheitlichen Rahmen \u00fcberf\u00fchren. Die Verwendung von\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\">KI-gest\u00fctzte Tools und standardisierte Arbeitsabl\u00e4ufe<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0unterst\u00fctzt eine verbesserte Datenqualit\u00e4t und Signalerkennung, w\u00e4hrend das \u00f6ffentliche Dashboard mit \u00fcbergeordneten Zielen \u00fcbereinstimmt\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\">Transparenz und digitale Zug\u00e4nglichkeit<\/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> Insgesamt ist das System darauf ausgelegt, die Sicherheits\u00fcberwachung \u00fcber den gesamten Lebenszyklus zu st\u00e4rken, w\u00e4hrend\u00a0<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">Aufrechterhaltung<\/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\">geringer Verwaltungsaufwand<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0f\u00fcr die Stakeholder.<\/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-1784422647 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1706181591\" 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>F\u00fcr wen ist das relevant?<\/h2>\n\t<div id=\"gap-989494211\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-989494211 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update ist relevant f\u00fcr Fachleute in <strong>Zulassungsangelegenheiten, Pharmakovigilanz, Qualit\u00e4tssicherung, Compliance und IT-Teams,<\/strong> insbesondere diejenigen, die verantwortlich sind f\u00fcr <strong>Meldung unerw\u00fcnschter Ereignisse, Sicherheitsdatenmanagement und Einreichungen bei den Aufsichtsbeh\u00f6rden<\/strong> in allen von der FDA regulierten Branchen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1706181591 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-537276690\" 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>N\u00e4chste Schritte<\/h2>\n\t<div id=\"gap-323555170\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-323555170 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organisationen sollten\u00a0<\/span><b><span data-contrast=\"auto\">\u00dcberpr\u00fcfen Sie die Funktionalit\u00e4t der AEMS-Plattform<\/span><\/b><span data-contrast=\"auto\">\u00a0und beurteilen, wie die aktuellen Berichtsprozesse mit dem neuen konsolidierten System \u00fcbereinstimmen. Verantwortliche Teams f\u00fcr\u00a0<\/span><b><span data-contrast=\"auto\">Meldung unerw\u00fcnschter Ereignisse und Bearbeitung von Beschwerden<\/span><\/b><span data-contrast=\"auto\">\u00a0werden ermutigt, sich mit dem\/der\/den\/den\u00a0<\/span><b><span data-contrast=\"auto\">Abfragefunktionen des \u00f6ffentlichen Dashboards<\/span><\/b><span data-contrast=\"auto\">\u00a0und die laufenden Aktualisierungen verfolgen. Im Laufe der Zeit k\u00f6nnten die Beteiligten Folgendes ber\u00fccksichtigen:\u00a0<\/span><b><span data-contrast=\"auto\">Anpassung interner Datenmanagement- und Signal\u00fcberwachungsprozesse<\/span><\/b><span data-contrast=\"auto\">\u00a0um den verbesserten Zugang zu produkt\u00fcbergreifenden Sicherheitserkenntnissen zu nutzen.<\/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\">Da sich die Regulierungssysteme weiterhin weiterentwickeln in Richtung\u00a0<\/span><b><span data-contrast=\"auto\">zentralisierte, KI-f\u00e4hige Plattformen<\/span><\/b><span data-contrast=\"auto\">, L\u00f6sungen wie\u00a0<\/span><a href=\"http:\/\/regask.com\/de\/\"><b><span data-contrast=\"auto\">RegASK<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0k\u00f6nnen Organisationen dabei unterst\u00fctzen, diesen Ver\u00e4nderungen einen Schritt voraus zu sein.\u00a0<a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a>\u00a0ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Analysen und Workflow-Orchestrierung, die globale Unternehmen in stark regulierten Branchen wie Konsumg\u00fcter und Life Sciences dabei unterst\u00fctzt, sich proaktiv in komplexen regulatorischen Umfeldern zu bewegen. Durch die Kombination von fortschrittlicher agentenbasierter KI mit Expertenwissen,\u00a0<a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a>\u00a0liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als 160 L\u00e4ndern.<strong><a href=\"http:\/\/regask.com\/de\/\"> Mehr erfahren<\/a> oder <a href=\"https:\/\/regask.com\/de\/demo-buchen\/\">Jetzt Demo buchen.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-537276690 > .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-1948902771\">\n\n\t<div id=\"col-1425948735\" 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>FAQs<\/h3>\n\t<div id=\"gap-1862969992\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1862969992 {\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\">Was ist das FDA-System zur \u00dcberwachung unerw\u00fcnschter Ereignisse (AEMS)?<\/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-15166170\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-15166170 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Der <strong>AEMS<\/strong> ist eine von der FDA ins Leben gerufene zentrale Plattform zur Verwaltung der Meldung unerw\u00fcnschter Ereignisse in allen von der FDA regulierten Produktkategorien.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1425948735 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-505200059\" 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\">Welche Arten von Berichten verarbeitet AEMS?<\/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-1148208285\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1148208285 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Das System unterst\u00fctzt <strong>Meldungen \u00fcber unerw\u00fcnschte Ereignisse, Verbraucherbeschwerden, Meldungen \u00fcber Fehlverhalten von Aufsichtsbeh\u00f6rden und Whistleblower-Meldungen. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-505200059 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-905814000\" 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\">K\u00f6nnen AEMS-Daten verwendet werden, um\u00a0<\/span><span class=\"NormalTextRun SCXW232842177 BCX0\">bestimmen<\/span><span class=\"NormalTextRun SCXW232842177 BCX0\">\u00a0Produktsicherheit oder Kausalit\u00e4t?<\/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-1609013871\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1609013871 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Nein. Die FDA gibt an, dass AEMS-Daten <strong>Es werden keine Kausalzusammenh\u00e4nge, Inzidenzraten oder definitive Sicherheitsprofile hergestellt.,<\/strong> und kann unvollst\u00e4ndige oder doppelte Berichte enthalten.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-905814000 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1735743777\" 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\">Wie kann\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW252578696 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW252578696 BCX0\">\u00a0Wie k\u00f6nnen sich Organisationen an AEMS anpassen?<\/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-773061026\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-773061026 {\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\/de\/\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW213849445 BCX0\">RegASK<\/span><\/a><\/strong><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0hilft Organisationen\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\">Monitor<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0Aktualisierungen der regulatorischen Bestimmungen, Optimierung der Compliance-Workflows und\u00a0<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">Hebelwirkung<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0KI-gest\u00fctzte Erkenntnisse<\/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> dies erm\u00f6glicht eine effizientere Anpassung an Systeme wie AEMS und verbessert die Praktiken im Bereich des Sicherheitsdatenmanagements.<\/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-1735743777 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Am 11. M\u00e4rz 2026 f\u00fchrte die US-amerikanische Arzneimittelbeh\u00f6rde FDA das Adverse Event Monitoring System (AEMS) ein, eine zentrale Plattform zur Vereinfachung der Meldung unerw\u00fcnschter Ereignisse in allen FDA-regulierten Produktkategorien. Das System betrifft Akteure in den Bereichen Pharmakovigilanz, Sicherheitsberichterstattung und Einhaltung regulatorischer Bestimmungen und deckt Sektoren wie Medizinprodukte, Impfstoffe, Medizinprodukte, Tabakwaren, Lebensmittel, Kosmetika und Tierarzneimittel ab.\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 v28.3 (Yoast SEO v28.4) - 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 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