{"id":4315,"date":"2024-02-13T07:20:33","date_gmt":"2024-02-13T07:20:33","guid":{"rendered":"https:\/\/www.bioevents.net\/horizon2024\/?page_id=4315"},"modified":"2025-04-02T06:52:13","modified_gmt":"2025-04-02T06:52:13","slug":"dear-colleagues-new","status":"publish","type":"page","link":"https:\/\/csmd-horizon.com\/dear-colleagues-new\/","title":{"rendered":"Dear Colleagues"},"content":{"rendered":"<div class=\"elementor-element elementor-element-a724a47 elementor-widget elementor-widget-text-editor\" data-id=\"a724a47\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">It is our great pleasure to welcome you to<em><strong> The CSMD-Horizon Special Conference: Clinical Evidence and Regulation for Medical Devices and IVDs with AI and Digital Health<\/strong>, <\/em>which will take place on <strong>4-5 November 2025<\/strong> in <strong>Brussels, Belgium<\/strong>.<\/span><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">This year, we are excited to merge two distinguished conferences: the <strong>Conference on Clinical Studies with Medical Devices and IVDs (CSMD)<\/strong> and <strong>The International Conference on Clinical Investigations, Regulation, and Market Access for Medical Devices and IVDs (Horizon)<\/strong>. By combining these events, we will focus on the rapidly evolving landscape of <em>AI, digital health, and software<\/em>\u2014exploring their impact on clinical evidence and regulatory strategies.<\/span><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">As AI and digital technologies continue to reshape healthcare, the need for clear regulatory frameworks and reliable clinical data has never been more crucial. This conference will address the intersection of clinical studies and regulatory affairs, specifically focusing on the challenges and opportunities presented by AI and digital health innovations.<\/span><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">Our program will delve into key issues at the intersection of AI, software, and medical devices, providing valuable insights into both current challenges and future opportunities. Topics include:<\/span><\/p>\n<ul>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Defining clinical evidence requirements<\/strong>\u00a0for digital health products from the perspectives of patients, payers, and regulators.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Navigating the evolving AI landscape<\/strong>\u00a0in medical devices\u2014striking the right balance between innovation, risk, and patient access.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Overcoming challenges in clinical study design<\/strong>\u00a0for software-based devices, with a focus on improving patient engagement and data quality.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Ethical Considerations &amp; Bias in AI<\/strong>\u00a0\u2013 Addressing fairness, transparency, and bias in AI-driven medical devices.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Real-World Evidence &amp; Post-Market Surveillance<\/strong> \u2013 How AI and software updates impact long-term safety, effectiveness, and regulatory compliance.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Exploring regulatory best practices <\/strong>and the potential role of AI in enhancing and streamlining clinical investigations and approval pathways<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">Our distinguished speakers will present practical examples, provide strategic insights, and offer solutions to the challenges faced by professionals in the fields of <strong>clinical affairs, regulatory affairs, R&amp;D and V&amp;V<\/strong>.<\/span><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">The event is designed for regulatory and clinical leaders in the medical device and IVD industry. Meet your colleagues and distinguished experts in clinical trials, reimbursement, regulations, and data management to share your thoughts, discuss hot topics and learn from each other.<\/span><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">We invite you to join us as a Sponsor or Exhibitor to benefit from the visibility and exposure to a broader audience of industry leaders and decision-makers.<\/span><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">We look forward to seeing you in Brussels for an engaging and insightful exchange of ideas.<\/span><\/p>\n<\/div>\n<\/div>\n<div class=\"elementor-element elementor-element-a724a47 elementor-widget elementor-widget-text-editor\" data-id=\"a724a47\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-element elementor-element-a724a47 elementor-widget elementor-widget-text-editor\" data-id=\"a724a47\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<table style=\"border-collapse: collapse; width: 45.8846%; height: 211px;\">\n<tbody>\n<tr style=\"height: 132px;\">\n<td style=\"width: 17.891%; height: 132px;\"><img decoding=\"async\" class=\"wp-image-5454 aligncenter\" src=\"https:\/\/www.bioevents.net\/csmd-horizon\/wp-content\/uploads\/sites\/153\/2025\/03\/Amie-Smirthwaite_round-246x300b.png\" alt=\"\" width=\"131\" height=\"160\" \/><\/td>\n<td style=\"width: 16.3114%; height: 132px;\"><img decoding=\"async\" class=\" wp-image-5354 aligncenter\" src=\"https:\/\/www.bioevents.net\/csmd-horizon\/wp-content\/uploads\/sites\/153\/2025\/03\/Danielle.png\" alt=\"\" width=\"128\" height=\"156\" \/><\/td>\n<\/tr>\n<tr style=\"height: 79px;\">\n<td style=\"width: 17.891%; height: 79px; text-align: center;\"><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Amie Smirthwaite<\/strong><\/span><br \/>\n<span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">Conference Co-Chair<\/span><\/td>\n<td style=\"width: 16.3114%; height: 79px; text-align: center;\"><span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\"><strong>Danielle Giroud<\/strong><\/span><br \/>\n<span style=\"font-family: 'trebuchet ms', geneva, sans-serif;\">Conference Co-Chair<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>It is our great pleasure to welcome you to The CSMD-Horizon Special Conference: Clinical Evidence and Regulation for Medical Devices and IVDs with AI and Digital Health, which will take place on 4-5 November 2025 in Brussels, Belgium. This year, we are excited to merge two distinguished conferences: the Conference on Clinical Studies with Medical [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-4315","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.8.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Dear Colleagues - CSMD-HORIZON<\/title>\n<meta name=\"description\" content=\"The CSMD-Horizon Special Conference: Clinical Evidence and Regulation for Medical Devices and IVDs with AI and Digital Health which will take place on 4-5 November 2025 in Brussels, Belgium.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/csmd-horizon.com\/dear-colleagues-new\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dear Colleagues - 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