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/Chicago
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20230312T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20231105T070000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20240310T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20241103T070000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20250309T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20251102T070000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240522T130000
DTEND;TZID=America/Chicago:20240522T140000
DTSTAMP:20240815T202821Z
CREATED:20240502T193435Z
LAST-MODIFIED:20240815T202821Z
UID:4841-1716382800-1716386400@criterionedge.com
SUMMARY:IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
DESCRIPTION:While the concept of a “performance evaluation” hasn’t changed much over the past two decades\, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). \nTo help manufacturers prepare and comply with the IVDR\, we have compiled some tips for developing and implementing a successful PEP as you prepare for your IVDR submissions. \nLearning Objectives: \n\nDescribe the scope and objectives of the PEP\, including considerations to identify the clinical claims\, the target population\, the clinical conditions\, the comparators\, and the endpoints.\nReview how to conduct a comprehensive systematic literature review\, a critical component of the PEP which provides the basis for the clinical evidence\, both favorable and unfavorable.\nDiscuss strategies to prepare a detailed scientific validity report (SVR)\, a new requirement under the IVDR to provide a clear rationale and scientific justification for the choice of the analyte or marker\, as well as the evidence of its association with the clinical condition or physiological state.\nDefine the requirements of the analytical performance report (APR)\, another new requirement under the IVDR which seeks to demonstrate the analytical performance of the IVD in terms of its ability to correctly measure the analyte or marker.\nClarify the expectations for sufficient clinical data contained within the clinical performance report (CPR)\, a key requirement under the IVDR that demonstrates the clinical performance of the IVD in terms of its ability to correctly identify or predict the clinical condition or physiological state of the target population\n\nWho is this webinar for?\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. \n  \nWATCH NOW
URL:https://criterionedge.com/event/ivdr-in-focus-tips-for-performance-evaluation-planning-to-support-your-transition-from-ivdd-to-ivdr-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/May-22-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR