{"id":13794,"date":"2025-03-21T13:26:11","date_gmt":"2025-03-21T12:26:11","guid":{"rendered":"https:\/\/q-finity.de\/?p=13794"},"modified":"2025-03-21T13:26:11","modified_gmt":"2025-03-21T12:26:11","slug":"europe-annual-conference-with-qfinity-12-14-may-2025","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/europe-annual-conference-with-qfinity-12-14-may-2025\/","title":{"rendered":"Europe Annual Conference with QFINITY | 12.-14. May 2025"},"content":{"rendered":"<p><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\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png\"><img data-opt-id=180216671  fetchpriority=\"high\" decoding=\"async\" class=\" wp-image-13728 alignright\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:127\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png\" alt=\"\" width=\"269\" height=\"114\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:127\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:324\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:298\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png 705w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:990\/h:418\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png 990w\" sizes=\"(max-width: 269px) 100vw, 269px\"><\/a><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>&acute;s CEO Oliver Herrmann and Senior Executive Frank Henrichmann will be at the ISPE Europe Annual Conference. The Conference will take place from May 12th-14th 2025 in London.<\/p>\n<h2>Oliver Herrmann will give a presentation about:<\/h2>\n<p><strong>Are the Current EU GCP CSV\/DI Requirements a Blueprint for Other GxPs?<\/strong><\/p>\n<p>This presentation will show you why it&rsquo;s so important to work with critical thinkers who have the subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized 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 defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own <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> system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility. Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11. That implies a significant change. This presentation will provide an overview of current GCP expectations. It will also show how to address the upcoming challenges in the digital transformation of clinical processes. Moreover it compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems 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>.<\/p>\n<h2><span data-teams=\"true\">&nbsp;Frank Henrichmann will present on the topic:&nbsp;<\/span><\/h2>\n<p><i><strong>&ldquo;Workshop &ldquo;Digital Transformation and GAMP: Implementing an AI Solution in a Pharma 4.0 Context&rdquo;<\/strong>&nbsp;<\/i><\/p>\n<p>Integrating innovative AI solutions serves as a cornerstone in the transition toward <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>-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP&reg; concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.<\/p>\n<p>This interactive workshop led by Frank Henrichmann, Martin Heitmann, Brandi Stockton and Paige Kane delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0&reg; and GAMP&reg;. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions. The main focus will be on methods for identifying and mitigating risks to patient safety, <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>, and product <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a>.<\/p>\n<p>Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> expectations and adhering to regulatory requirements.<\/p>\n<p>More information about the Europe Annual Conference can be found <a href=\"https:\/\/ispe.org\/conferences\/2025-europe-annual-conference\">here<\/a>.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>QFINITY\u00b4s CEO Oliver Herrmann and Senior Executive Frank Henrichmann will be at the ISPE Europe Annual Conference. The Conference will take place from May 12th-14th 2025 in London. Oliver Herrmann will give a presentation about: Are the Current EU GCP CSV\/DI Requirements a Blueprint for Other GxPs? This presentation will show you why it&#8217;s so [&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-13794","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>Europe Annual Conference with QFINITY | May 2025<\/title>\n<meta name=\"description\" content=\"QFINITY\u00b4s CEO Oliver Herrmann and Senior Executive Frank Henrichmann will be at the ISPE Europe Annual Conference.\" \/>\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\/europe-annual-conference-with-qfinity-12-14-may-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Europe Annual Conference with QFINITY | 12.-14. May 2025\" \/>\n<meta property=\"og:description\" content=\"QFINITY\u00b4s CEO Oliver Herrmann and Senior Executive Frank Henrichmann will be at the ISPE Europe Annual Conference.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/europe-annual-conference-with-qfinity-12-14-may-2025\/\" \/>\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=\"2025-03-21T12:26:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/02\/Bildschirmfoto-2025-02-10-um-16.47.52.png\" \/>\n\t<meta property=\"og:image:width\" content=\"990\" \/>\n\t<meta property=\"og:image:height\" content=\"418\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/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=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/q-finity.de\/en\/europe-annual-conference-with-qfinity-12-14-may-2025\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/europe-annual-conference-with-qfinity-12-14-may-2025\/\"},\"author\":{\"name\":\"Maike Henrichmann\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/9f304da5294d2d15c3f03d2521c47921\"},\"headline\":\"Europe Annual Conference with QFINITY | 12.-14. 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