BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Criterion Edge - ECPv6.18.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
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:20220302T110000
DTEND;TZID=America/Los_Angeles:20220302T120000
DTSTAMP:20220310T182318Z
CREATED:20220209T013909Z
LAST-MODIFIED:20220310T182318Z
UID:3272-1646218800-1646222400@criterionedge.com
SUMMARY:IVD Deep Dive Series Part 1
DESCRIPTION:Safety & Performance Objectives and Acceptance Criteria\nHow do I define acceptance criteria and how do I define safety and performance objectives?\nWhat are the biggest pitfalls or “Achille’s heels” to watch out for in identifying safety and performance measures? \nIn this webinar\, we’ll take a deep dive into the best practices to identify relevant and appropriate Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First\, using a case study example\, we’ll discuss considerations and provide tips to help you select relevant Safety & Performance Objectives for your IVD. Additionally\, we’ll discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Then we’ll explain how these objectives help establish Acceptance Criteria\, a critical input for establishing the SOA in your PER. \nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve performance evaluation reports for IVDR submissions. \n  \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746 \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-1/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVD-Deep-Dive-pt-1-cover-slide-030222.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
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
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220330T110000
DTEND;TZID=America/Los_Angeles:20220330T120000
DTSTAMP:20220330T223102Z
CREATED:20220216T200837Z
LAST-MODIFIED:20220330T223102Z
UID:3339-1648638000-1648641600@criterionedge.com
SUMMARY:IVD Deep Dive Series Part 2
DESCRIPTION:Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report\nIn Part 1 of our IVD Deep Dive series\, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD. \nPresented from the point of view of seasoned MDR-compliant CER medical writers\, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR). \nKey Takeaways: \n\nDiscuss the purpose of the CPR and its role as a critical component of the PER\nIdentify sources of clinical data and analyze those data within the context of the\nperformance endpoints and acceptance criteria presented in the SVR\nDemonstrate how to extract\, organize\, and appraise these data within the CPR\n\nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical performance reports for IVDR submissions. \n  \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746 \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-2-clinical-data-sources/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVD-Deep-Dive-series-part-2-cover-033022.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR