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:20220601T110000
DTEND;TZID=America/Los_Angeles:20220601T120000
DTSTAMP:20220602T200132Z
CREATED:20220512T170649Z
LAST-MODIFIED:20220602T200132Z
UID:3576-1654081200-1654084800@criterionedge.com
SUMMARY:Scoping Your MDR & IVDR Writing Projects
DESCRIPTION:Scoping Your MDR and IVDR Writing Projects – The Forgotten Step\nIn most of our webinars\, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However\, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? \nIn this webinar\, we’ll discuss the process of scoping a writing project for either MDR or IVDR. We will share the key questions we ask our clients before we start writing and what key inputs are necessary to kickstart the project and ensure you’re starting on the right foot. \nWe hope to \n\nGive insight into planning realistic timelines and assessing your team’s bandwidth to complete your project\nProvide examples of key documents and inputs needed early in the writing process\nDescribe where these pieces fit within the Clinical Evaluation Report or Performance Evaluation Report templates\n\nWho is this forum for?\nThose regulatory\, quality and clinical leaders and teams who are tasked with the development\, writing\, review\, or approval of Clinical Evaluation Reports for MDR submissions or Performance Evaluation Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend. \nClick here to watch the recording of this webinar. \n6 Project Management Secrets Used by Top Medical Writers\nI bet when you became a medical writer\, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant\, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered\, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects\, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers\, you’re not alone. \nClick here to read these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements. \nAt Criterion Edge\, our clients enjoy our transparency in the services we provide as our candid scoping includes a time frame for delivering the CER and detailed information on gaps in compliance. All of our writers have experience writing CERs and are up to date on current regulations. Providing a comprehensive analysis and subsequent solutions sets us apart from other vendors. Contact us if you would like to have a conversation about what we can do to help with your writing and regulatory needs. 
URL:https://criterionedge.com/event/scoping-your-mdr-ivdr-writing-projects/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Scoping-Your-MDR-and-IVDR-Projects-060122.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220615T110000
DTEND;TZID=America/Los_Angeles:20220615T120000
DTSTAMP:20220616T005819Z
CREATED:20220602T195713Z
LAST-MODIFIED:20220616T005819Z
UID:3622-1655290800-1655294400@criterionedge.com
SUMMARY:The Role of RA in the Clinical and Performance Evaluation Process
DESCRIPTION:The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success\nRegulatory Affairs plays a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process\, from project implementation through report writing and finally\, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables\, this presentation examines key drivers of project success\, such as early assessment of data sufficiency\, equivalence considerations\, internal readiness of critical documentation\, project planning strategies\, and how to identify potential roadblocks and proactively find solutions to common problems. \nClick here to watch the recording of this webinar. \nKey Takeaways:\n1. Identify critical components of the clinical evaluation process and strategies to support project success. \n2. Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process. \n3. Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission. \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, answers will be limited to 3 minutes per question. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nThinking about using an outsourced regulatory writing team\, but aren’t sure of the advantages?\nIn today’s medical device and pharmaceutical environment\, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. \nRead our blog post to help decide if outsourcing is the right decision for your team. \nKey Strategies to Support Project Success for the Clinical and Performance Evaluation Process\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/strategies-to-support-project-success-in-the-clinical-and-performance-evaluation-process/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/the-role-of-RA-webinar-cover-061522.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR