{"id":11911,"date":"2024-02-03T10:51:19","date_gmt":"2024-02-03T09:51:19","guid":{"rendered":"https:\/\/q-finity.de\/?p=11911"},"modified":"2024-02-03T10:51:19","modified_gmt":"2024-02-03T09:51:19","slug":"acdm-annual-meeting-03-05-march-2024","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/acdm-annual-meeting-03-05-march-2024\/","title":{"rendered":"ACDM Annual Meeting | 03.-05. March 2024"},"content":{"rendered":"<p>Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> will be at the ACDM Annual Meeting in Copenhagen. This Meeting will take place from 3<i>rd<\/i>&ndash; to 5<i>th<\/i> March.<a href=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png\"><img data-opt-id=764480698  fetchpriority=\"high\" decoding=\"async\" class=\"alignright wp-image-11912\" title=\"ACDM Annual Meeting\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:91\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png\" alt=\"ACDM Annual Meeting\" width=\"534\" height=\"162\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:91\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1030\/h:313\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 1030w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:233\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1536\/h:466\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 1536w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1920\/h:583\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 2048w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1500\/h:455\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 1500w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:214\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png 705w\" sizes=\"(max-width: 534px) 100vw, 534px\"><\/a><\/p>\n<p>We are very pleased that Frank Henrichmann will present on that conference on the topic of &ldquo;How to comply with EU Guideline on computerised systems and electronic <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> in clinical trials&rdquo;. This regulatory guideline was released by the EMA in 2023. It is the most extensive and detailed guidance ever published specifically for GCP systems. The EMA guideline covers key definitions and principles like Source <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a>, Responsibilities, and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">Data Integrity<\/a>, expectations on Computerized systems, and their validation, including vendor management. Electronic <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a>, from capturing <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> to <a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">Audit<\/a> trail review and migration, are covered along with security expectations.<\/p>\n<p>His presentation will focus on the key topics addressed in that guideline and challenges in the adoption of it.<\/p>\n<p>What were the reasons and intentions of the regulators when creating this guidance?<\/p>\n<p>What are the most critical changes, and how can we address them?<\/p>\n<p>The key focus of the presentation will be the validation of computerised systems used within clinical trials at clinical sites. He will also talk about the expectations on vendor oversight and collaboration especially in the usage of Software-as-a-Service (SaaS) and the detailed expectations on <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> archiving and retention.<\/p>\n<p>We are looking forward to meeting you there and to discuss technology <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services. If you need&hellip;\" class=\"encyclopedia\">quality management<\/a> topics with you.<\/p>\n<p>For more information about the ACDM Annual Meeting click <a href=\"https:\/\/acdmconference.org\/acdm24-programme\/\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen. This Meeting will take place from 3rd&#8211; to 5th March. We are very pleased that Frank Henrichmann will present on that conference on the topic of \u201cHow to comply with EU Guideline on computerised systems [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[38],"tags":[],"class_list":["post-11911","post","type-post","status-publish","format-standard","hentry","category-meet-qfinity-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ACDM Annual Meeting<\/title>\n<meta name=\"description\" content=\"Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/acdm-annual-meeting-03-05-march-2024\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ACDM Annual Meeting | 03.-05. March 2024\" \/>\n<meta property=\"og:description\" content=\"Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/acdm-annual-meeting-03-05-march-2024\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/QFINITY\" \/>\n<meta property=\"article:published_time\" content=\"2024-02-03T09:51:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:91\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/02\/Bildschirmfoto-2024-02-03-um-10.37.23.png\" \/>\n<meta name=\"author\" content=\"Maike Henrichmann\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:site\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Maike Henrichmann\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/q-finity.de\/en\/acdm-annual-meeting-03-05-march-2024\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/acdm-annual-meeting-03-05-march-2024\/\"},\"author\":{\"name\":\"Maike Henrichmann\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/9f304da5294d2d15c3f03d2521c47921\"},\"headline\":\"ACDM Annual Meeting | 03.-05. 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