BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Criterion Edge - ECPv6.18.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Criterion Edge
X-ORIGINAL-URL:https://criterionedge.com
X-WR-CALDESC:Events for Criterion Edge
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20210314T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20211107T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20220313T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20221106T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20230312T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20231105T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220309T110000
DTEND;TZID=America/Los_Angeles:20220309T114500
DTSTAMP:20220310T010736Z
CREATED:20220216T200043Z
LAST-MODIFIED:20220310T010736Z
UID:3337-1646823600-1646826300@criterionedge.com
SUMMARY:[Ask the Expert] Clinical Data for IVD
DESCRIPTION:Clinical Data for IVD: What is it and How Do I Find It?\nDo you have questions about how to generate\, collect\, analyze\, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing\, we will provide insights and suggestions to help make the process of data collection\, extraction\, and presentation more streamlined. \nThis forum answers question like these and more. Click here to watch the recording. \nWho watch this forum?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve performance evaluation reports for IVDR submissions.\n\n\nA Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness\nThe implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore\, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition\, establishing clinical performance of their products is key. However\, many manufacturers may not be familiar with or have the capability to perform rigorous\, IVDR-compliant systematic literature reviews (SLR). Finally\, screening\, selection and data extraction are typically challenges for manufacturers as well. \nIn this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next\, using case studies\, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). \nKey Takeaways:\n\nReview the essential steps for conducting a robust\, methodologically-sound systematic literature review\nUsing a typical case study scenario\, learn how to effectively search\, identify\, screen\, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.\n\nWatch this webinar recording.
URL:https://criterionedge.com/event/ask-the-expert-clinical-data-for-ivd/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-Clinical-Data-for-IVD-3.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR