{"id":2847,"date":"2023-01-19T14:38:07","date_gmt":"2023-01-19T14:38:07","guid":{"rendered":"https:\/\/www.bioevents.net\/csmd2023\/?page_id=2847"},"modified":"2023-02-21T07:50:36","modified_gmt":"2023-02-21T07:50:36","slug":"pre-conference-workshop-2","status":"publish","type":"page","link":"https:\/\/csmd2023.com\/pre-conference-workshop-2\/","title":{"rendered":"Pre-Conference Workshop"},"content":{"rendered":"

Clinical Evaluation Documents under EU MDR \u2013 in Depth Review<\/strong><\/span><\/p>\n


\n<\/strong>Wednesday, 29 March 2023<\/strong><\/span><\/em><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
08:00-09:00<\/span><\/td>\nRegistration<\/strong><\/span><\/td>\n<\/tr>\n
08:50-09:00<\/span><\/td>\nIntroduction
\n<\/strong><\/span>Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland<\/em><\/span><\/span><\/td>\n<\/tr>\n
09:00-10:30<\/span><\/td>\nRegulatory Overview of the Clinical Evaluation Process<\/strong><\/span><\/td>\n<\/tr>\n
<\/td>\n– Review of EU regulations regarding Clinical Evaluation (EU-MDR and related guidance documents)
\n<\/em><\/span>– Before starting a clinical evaluation plan \u2013 how does risk management relate?
\n<\/em><\/span>– When to start the clinical evaluation process in new product development
\n<\/em><\/span>\u00a0 Course lead: Elina Buitrago, <\/em><\/strong>PhD (Medical Writer), MD-CLINICALS, Switzerland<\/em><\/span><\/span><\/td>\n<\/tr>\n
10:30-11:00<\/span><\/td>\nCoffee Break & Networking\u00a0<\/strong><\/span><\/td>\n<\/tr>\n
11:00-12:30<\/span><\/td>\nDevelop a Comprehensive Clinical Evaluation Plan (CEP) <\/strong><\/span><\/td>\n<\/tr>\n
<\/td>\n– Contents of a clinical evaluation plan
\n<\/em><\/span>– Quantified claims (safety, performance and clinical benefits)
\n<\/em><\/span>– Position your device<\/em><\/span>
\n<\/em><\/span>– Available data and preparing meaningful literature search protocols and appraisal plans
\n<\/em><\/span>\u00a0 Course lead: Elina Buitrago, <\/strong>PhD (Medical Writer), MD-CLINICALS, Switzerland<\/em><\/span><\/span><\/td>\n<\/tr>\n
12:30-14:00<\/span><\/td>\nLunch Break & Networking\u00a0<\/strong><\/span><\/td>\n<\/tr>\n
14:00-15:00<\/span><\/td>\nWrite your Clinical Evaluation Report (CER)<\/strong><\/span><\/td>\n<\/tr>\n
<\/td>\n– Clinical Development Plan
\n– Contents of a clinical evaluation report
\n<\/em><\/span>– Analysis of the different data sets
\n<\/em><\/span>– Discussion and conclusions
\n<\/em><\/span>– What\u2019s next \u2013 the PMCF Plan and PMS plan
\n<\/em><\/span>\u00a0 \u00a0Course lead:<\/span> Danielle Giroud<\/strong>, CEO MD-CLINICALS, Switzerland & Elina Buitrago, <\/strong>PhD (Medical Writer), MD-CLINICALS, Switzerland<\/em><\/span><\/em><\/span><\/td>\n<\/tr>\n
15:00-15:30<\/span><\/td>\nCoffee Break & Networking\u00a0<\/strong><\/span><\/td>\n<\/tr>\n
15:30-17:00<\/span><\/td>\nDevelop PMCF Plan and Other Documents<\/strong><\/span><\/td>\n<\/tr>\n
<\/td>\n– Contents of a Post Market Clinical follow up plan (PMCF)
\n<\/em><\/span>– How to determine PMCF activities \u2013 an overview of the different options
\n<\/em><\/span>– Other documents such as Summary of Safety and Clinical Performance (SSCP) \u2013 for users and
\nSSCP for patients
\n<\/em><\/span>\u00a0 Course lead:<\/span> Danielle Giroud<\/strong>, CEO MD-CLINICALS, Switzerland & Elina Buitrago, <\/strong>PhD (Medical Writer), MD-CLINICALS, Switzerland<\/em><\/span><\/em><\/span><\/td>\n<\/tr>\n
17:00<\/span><\/td>\nEnd of workshop<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Clinical Evaluation Documents under EU MDR \u2013 in Depth Review Wednesday, 29 March 2023 08:00-09:00 Registration 08:50-09:00 Introduction Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland 09:00-10:30 Regulatory Overview of the Clinical Evaluation Process – Review of EU regulations regarding Clinical Evaluation (EU-MDR and related guidance documents) – Before starting a clinical evaluation plan \u2013 how […]<\/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-2847","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nPre-Conference Workshop - CSMD2023<\/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:\/\/csmd2023.com\/pre-conference-workshop-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pre-Conference Workshop - 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