{"id":3574,"date":"2025-08-13T12:06:20","date_gmt":"2025-08-13T10:06:20","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=about-us-fgk-cro&#038;p=3574"},"modified":"2025-11-21T10:59:18","modified_gmt":"2025-11-21T09:59:18","slug":"tochterunternehmen","status":"publish","type":"about-us-fgk-cro","link":"https:\/\/fgk-group.com\/de\/fgk-cro\/ueber-uns\/tochterunternehmen\/","title":{"rendered":"Tochterunternehmen"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3574\" class=\"elementor elementor-3574 elementor-503\" data-elementor-post-type=\"about-us-fgk-cro\">\n\t\t\t\t<div class=\"elementor-element elementor-element-787d0f3 e-con-full e-flex e-con e-child\" data-id=\"787d0f3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5f2765b e-con-full e-flex e-con e-child\" data-id=\"5f2765b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e738ff8 elementor-widget elementor-widget-image\" data-id=\"e738ff8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/fgk-representative-service-logo.svg\" class=\"attachment-full size-full wp-image-3603\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-46dd87f e-con-full e-flex e-con e-child\" data-id=\"46dd87f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc7138b elementor-widget elementor-widget-heading\" data-id=\"fc7138b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FGK Representative Service<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-307b5f1 elementor-widget elementor-widget-text-editor\" data-id=\"307b5f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>FGK Representative Service erf\u00fcllt die rechtlichen Anforderungen von Sponsorunternehmen, die keinen Unternehmenssitz innerhalb der Europ\u00e4ischen Union, der Schweiz und dem Vereinigten K\u00f6nigreich haben, so dass diese klinische Studien in der jeweiligen Region durchf\u00fchren k\u00f6nnen.<\/p><p>Die Verordnungen (EU) 536\/2014 f\u00fcr klinische Arzneimittelstudien (CTR), die Verordnung (EU) 2017\/745 f\u00fcr Medizinprodukte (MDR) und die Verordnung (EU) 2017\/746, die In-Vitro-Diagnostic Medical Device Regulation (IVDR) verlangen, dass ein Sponsor, der nicht in der EU ans\u00e4ssig ist, einen Vertreter benennen muss, wenn er eine klinische Studie in der EU durchf\u00fchren m\u00f6chte.<\/p><p>Auch die Schweizer Verordnungen \u00fcber klinische Versuche mit Arzneimitteln und klinische Pr\u00fcfungen mit Medizinprodukten verlangen einen Schweizer Vertreter, wenn der Sponsor nicht in der Schweiz ans\u00e4ssig ist.<\/p><p>Seit dem Brexit ist auch im Vereinigten K\u00f6nigreich ein lokaler Vertreter f\u00fcr die Durchf\u00fchrung klinischer Studien vorgeschrieben, vorl\u00e4ufig wird jedoch noch ein Vertreter in der EU akzeptiert.<\/p><p><strong><a href=\"\/de\/fgk-rs\/\">www.fgk-group.com\/de\/fgk-rs\/<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4537a59 e-con-full e-flex e-con e-child\" data-id=\"4537a59\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2cfc209 e-con-full e-flex e-con e-child\" data-id=\"2cfc209\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2be72c8 elementor-widget elementor-widget-image\" data-id=\"2be72c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/fgk-pharmacovigilance-logo.svg\" class=\"attachment-full size-full wp-image-3604\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7d54eaf e-con-full e-flex e-con e-child\" data-id=\"7d54eaf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-acf985f elementor-widget elementor-widget-heading\" data-id=\"acf985f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FGK Pharmacovigilance GmbH<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-157ec58 elementor-widget elementor-widget-text-editor\" data-id=\"157ec58\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Die FGK Pharmacovigilance GmbH ist ein wachsendes Tochterunternehmen der FGK Clinical Research GmbH, einer Full-Service-Organisation f\u00fcr klinische Forschung mit Hauptsitz in M\u00fcnchen, Deutschland. FGK-PV ist nicht nur ein junges, aufstrebendes und attraktives Unternehmen, sondern wird auch von erfahrenen Experten geleitet, die Kenntnisse der Beh\u00f6rden auf beiden Seiten des Atlantiks, bew\u00e4hrte Erfahrung in der Sicherheit von Arzneimitteln und Medizinprodukten und eine ruhige Hand mitbringen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89e7c92 elementor-widget elementor-widget-text-editor\" data-id=\"89e7c92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: #000000;\"><strong>FGK PV bietet:<\/strong><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4090fd9 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"4090fd9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Management von unerw\u00fcnschten Ereignissen und Signalen aus einer Vielzahl von Quellen<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Erstellung von Perdiodic Safety Update Reports<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Erstellung von Ad-hoc-Safety Reports, Stellungnahmen oder Erkl\u00e4rungen, die speziell auf die Anforderungen der zust\u00e4ndigen Beh\u00f6rden zugeschnitten sind<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Charakterisierung des Sicherheitsprofils eines Arzneimittels<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Planung von Pharmakovigilanz-Aktivit\u00e4ten zur Verbesserung der Kenntnisse \u00fcber das Sicherheitsprofil des Arzneimittels<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25156e8 elementor-widget elementor-widget-text-editor\" data-id=\"25156e8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Management von Aktivit\u00e4ten zur Risikominimierung, einschlie\u00dflich der Bewertung der Wirksamkeit dieser Aktivit\u00e4ten<\/p><p><strong><a href=\"\/de\/fgk-pv\/\">www.fgk-group.com\/de\/fgk-pv\/<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"parent":0,"menu_order":0,"template":"","class_list":["post-3574","about-us-fgk-cro","type-about-us-fgk-cro","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tochterunternehmen - FGK Group<\/title>\n<meta name=\"description\" content=\"Lernen Sie hier die Tochterunternehmen von FGK Clinical Research kennen.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/fgk-cro\/ueber-uns\/tochterunternehmen\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tochterunternehmen - FGK 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