{"id":2829,"date":"2023-01-19T13:57:23","date_gmt":"2023-01-19T13:57:23","guid":{"rendered":"https:\/\/www.bioevents.net\/csmd2023\/?page_id=2829"},"modified":"2023-01-19T13:57:23","modified_gmt":"2023-01-19T13:57:23","slug":"pre-conference-workshop","status":"publish","type":"page","link":"https:\/\/csmd2023.com\/pre-conference-workshop\/","title":{"rendered":"Pre-Conference Workshop"},"content":{"rendered":"

PRE-CONFERENCE WORKSHOP<\/strong><\/span><\/p>\n

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


\n<\/strong>Wednesday, 29 March 2023<\/strong><\/span><\/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>\nWorkshop Opening & Welcome
\n<\/strong><\/span>Workshop Chair: Danielle Giroud<\/em><\/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: Danielle Giroud<\/strong>, CEO MD-CLINICALS, Switzerland<\/em><\/span><\/td>\n<\/tr>\n
10:30-11:00<\/span><\/td>\nCoffee Break, Networking and Visit the Exhibition<\/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
\n<\/em><\/span>– Clinical development plan
\n<\/em><\/span>– Available data and preparing meaningful literature search protocols and appraisal plans
\n<\/em><\/span>\u00a0 Course lead: Danielle Giroud<\/strong>, CEO MD-CLINICALS, Switzerland<\/em><\/span><\/td>\n<\/tr>\n
12:30-13:30<\/span><\/td>\nLunch Break, Networking and Visit the Exhibition<\/strong><\/span><\/td>\n<\/tr>\n
13:30-15:00<\/span><\/td>\nWrite your Clinical Evaluation Report (CER)<\/strong><\/span><\/td>\n<\/tr>\n
<\/td>\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<\/em><\/td>\n<\/tr>\n
15:00-15:30<\/span><\/td>\nCoffee Break, Networking and Visit the Exhibition<\/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<\/em><\/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":"

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