{"id":2908,"date":"2023-04-14T15:33:36","date_gmt":"2023-04-14T15:33:36","guid":{"rendered":"https:\/\/www.bioevents.net\/euroleuk2023\/?page_id=2908"},"modified":"2024-06-18T07:12:28","modified_gmt":"2024-06-18T07:12:28","slug":"conference-chairs","status":"publish","type":"page","link":"https:\/\/horizon-2024.com\/conference-chairs\/","title":{"rendered":"Conference Chair"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignnone wp-image-4936\" src=\"https:\/\/horizon2024.com\/wp-content\/uploads\/sites\/137\/2024\/05\/Amie-Smirthwaite_round-246x300.png\" alt=\"\" width=\"137\" height=\"167\" srcset=\"https:\/\/horizon-2024.com\/wp-content\/uploads\/sites\/137\/2024\/05\/Amie-Smirthwaite_round-246x300.png 246w, https:\/\/horizon-2024.com\/wp-content\/uploads\/sites\/137\/2024\/05\/Amie-Smirthwaite_round.png 500w\" sizes=\"(max-width: 137px) 100vw, 137px\" \/><\/p>\n<p><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; font-size: 18px; color: #000000;\"><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; color: #000000;\">Amie Smirthwaite<\/span><br \/>\n<em>Senior Vice President, Intelligence and Innovation RQM+, UK<\/em><\/span><\/p>\n<ul>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; color: #000000;\">Amie Smirthwaite has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years\u2019 experience in medical devices, spanning new product development, regulatory and quality, with a particular focus on clinical evidence. She leads RQM+\u2019s Intelligence and Innovation team.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; color: #000000;\">Amie joined RQM+ in May 2020, following 12 years at BSI, where she was Global Head of Clinical Compliance. She established BSI\u2019s clinical compliance team and led clinical aspects of BSI\u2019s successful designation under both MDD and MDR. Amie has been involved in numerous expert working groups within the EU, determining requirements for the interpretation and implementation of clinical evidence.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; color: #000000;\">As a member of the European Commission Clinical Investigations and Evaluations Expert Group and other European Working Groups, she contributed to many MDCG and MedDev guidance documents, including guidance on SSCP, \u201csufficient clinical evidence\u201d, equivalence, PMCF, and PSURs.<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; color: #000000;\">Amie is currently a member of ISO technical committees CH\/194 (Biological and clinical evaluation of medical devices), CH\/150 (Implants for surgery), and CH\/210\/4 Risk analysis for medical devices and is on the Advisory Boards of NORE (Network of Orthopaedic Registries of Europe) and CORE-MD (Coordinating Research and Evidence for Medical Devices, European Union Horizon 2020 project).<\/span><\/li>\n<li><span style=\"font-family: 'trebuchet ms', geneva, sans-serif; color: #000000;\">Amie has developed extensive training materials in clinical evaluation, technical file construction, biological safety, risk management and ISO 13485. and has trained hundreds of manufacturers and notified body reviewers in these requirements.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Amie Smirthwaite Senior Vice President, Intelligence and Innovation RQM+, UK Amie Smirthwaite has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years\u2019 experience in medical devices, spanning new product development, regulatory and quality, with a particular focus on clinical evidence. She leads RQM+\u2019s Intelligence and Innovation team. [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2908","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Conference Chair - Horizon2024<\/title>\n<meta name=\"description\" content=\"Horizon 2024: Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs, which will take place 20-21 November 2024 in Copenhagen, Denmark\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/horizon-2024.com\/conference-chairs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Conference Chair - 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