{"id":10105,"date":"2026-07-15T12:56:14","date_gmt":"2026-07-15T10:56:14","guid":{"rendered":"https:\/\/ekfz.uni-goettingen.de\/2026-06-18-i-ekfz-academy-workshop\/"},"modified":"2026-07-15T13:13:50","modified_gmt":"2026-07-15T11:13:50","slug":"2026-06-18-i-ekfz-academy-workshop","status":"publish","type":"page","link":"https:\/\/ekfz.uni-goettingen.de\/en\/2026-06-18-i-ekfz-academy-workshop\/","title":{"rendered":"2026-06-18 I EKFZ Academy Workshop"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row row_type=&#8221;main-section&#8221; stukram_section_layout=&#8221;section_grid&#8221;][vc_column][vc_column_text]\n<h3><strong><span class=\"HwtZe\" lang=\"de\"><span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\">&#8220;Imagine you are founding a university spin-off with the goal of bringing a medical device or gene therapy to market. When should a Quality Management System (QMS) be implemented?&#8221;<\/span><\/span><\/span><\/strong><\/h3>\n<p>With this targeted question, our Quality Management &amp; Regulatory Affairs team opened the EKFZ Academy workshop on &#8220;Implementing a Quality Management System for Combination Products,&#8221; immediately highlighting how crucial it is to implement a QMS early in the development process. <span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\">A well-established QMS bridges the gap from laboratory research to market launch and is essential for complying with regulatory requirements and managing risks.<\/span><\/span><span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\"> Fenja Hanneken and Mohamad Mersalli guided participants through the processes and procedures required for the introduction and implementation of a QMS in an academic spin-off, shedding light on the quality requirements for both gene therapies and medical devices.<\/span><\/span> <span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\">In this context, they explained the challenges and synergies arising from linking different regulatory requirements with the structures of academic institutions.<\/span><\/span> <span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\">Following the interactive workshop, participants had the opportunity to discuss open questions with the speakers \u2013 while enjoying an ice cream in the warm summer weather.<\/span><\/span><\/p>\n<p>A big thank you to the entire Quality Management &amp; Regulatory Affairs team for this insightful workshop; we are already looking forward to further joint training sessions![\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;10101&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;10103&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row row_type=&#8221;main-section&#8221; stukram_section_layout=&#8221;section_grid&#8221;][vc_column][vc_column_text] &#8220;Imagine you are founding a university spin-off with the goal of bringing a medical device or gene therapy to&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":23,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-10105","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>2026-06-18 I EKFZ Academy Workshop - ekfz<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ekfz.uni-goettingen.de\/en\/2026-06-18-i-ekfz-academy-workshop\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2026-06-18 I EKFZ Academy Workshop - ekfz\" \/>\n<meta property=\"og:description\" content=\"[vc_row row_type=&#8221;main-section&#8221; 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