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DTSTART;TZID=America/Los_Angeles:20220202T110000
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UID:3245-1643799600-1643803200@criterionedge.com
SUMMARY:How to Establish the State-of-the-Art Within the Scientific Validity Report
DESCRIPTION:How to Establish the State-of-the-Art Within the Scientific Validity Report\nIn this presentation\, Criterion Edge’s Principal Medical Writer\, Dr. Sarah Chavez\, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation process. In addition\, you will learn how to assess your SVR project for unanticipated roadblocks and delays. Finally\, you’ll see how indecision or incomplete supporting documents can negatively impact SOA (and therefore\, SVR) quality and timelines.  \nKey Takeaways: \n\nThe foundational role of the SOA in the SVR \nThe required components of the SOA such as the safety and performance objectives \nThe importance of a robust systematic literature review (SLR) to support your SOA \n\nWho should watch the recording?\n\n\nThose Regulatory\, Quality and Clinical leaders\, regulatory writers\, and teams who are develop\, write\, review\, or approve of Performance Evaluation Reports for EU IVDR submission. Anyone interested in learning more about IVDR requirements for PERs is encouraged to attend as well. \nClick here to watch the recording of this webinar.\n\n\n\nA Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness\n\n\nWith the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products\, however many manufacturers may not be familiar with or have the capability to perform rigorous\, IVDR-compliant systematic literature reviews (SLR)\, screening\, selection and data extraction. \nIn this practical presentation\, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies\, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). Watch this webinar.
URL:https://criterionedge.com/event/how-to-establish-the-state-of-the-art-within-the-scientific-validity-report/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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DTSTART;TZID=America/Los_Angeles:20220223T110000
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DTSTAMP:20220224T183558Z
CREATED:20220208T231550Z
LAST-MODIFIED:20220224T183558Z
UID:3300-1645614000-1645617600@criterionedge.com
SUMMARY:IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation
DESCRIPTION:IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\n\nIn this webinar\, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First\, we know a PER has many moving pieces. Accordingly\, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next\, using our CE Scoping checklist\, we will walk through the essential IVDR documents. Additionally\, we’ll discuss SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nGoals for this webinar:\n\nEmphasize the importance of scoping\nDiscuss how to develop a checklist\nIllustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process\n\nWho should watch this webinar? \nThose Regulatory\, Quality and Clinical leaders and teams who are tasked with the development\, writing\, review or approval of performance evaluation reports for IVDR submissions. \nClick here to watch the recording of this webinar. \nLeveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMCF Processes\nWatch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR? \nKey takeaways from the discussion include: \n\nEarly implementation of structural process change across the organization can empower future success with IVDR submissions to the notified bodies\nWhat are the key documents and processes essential for successful alignment with IVDR regulations\nThe importance of understanding the critical role of proactive and ongoing Systematic Literature Review search and screening activities\nUnexpected roadblocks\n\n\n\nWho should watch this webinar?\nAll regulatory\, clinical\, and scientific professionals who develop\, write\, review\, or approve scientific manuscripts\, reports\, presentations\, and other forms of communications in the medical device\, pharmaceutical\, and diagnostics space. \nWatch the recording.
URL:https://criterionedge.com/event/ivdr-essentials-performance-evaluation-report-early-planning-and-preparation/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVDR-Essentials-cover-slide-022322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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