BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:58972 DTSTAMP:20260526T015244Z SUMMARY:edical Device Postmarketing Vigilance Reporting: Update and Ex pectations for Manufacturers - Webinar By GlobalCompliancePanel DESCRIPTION:Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Pr oviding more guidance than the previous version, the new document incl udes new reporting terminology and concepts such as \"periodic summary reporting\" and \"trend reporting.\" In addition, the terms \"advisor y notice,\" \"near incident,\" and \"recall\" have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents to follow them as well.  This session will address topics such as new definitions; the guideline's extended scope, repor ting criteria/timelines, filing safety notices and field safety correc tive actions, and more. The new guidelines contain some controversial aspects, including the extension of their scope and the new approach o f immediate reporting unless delays can be justified.  Areas Covered in the Session:\nExamine the latest changes to MEDDEV and Medical Devi ce Vigilance and impact on medical device manufacturers\nRecognize the \"new\" terminology and concepts\nReport incidents as recommended by the guidance\nExamine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines\nMan age expectations for reporting and timelines\nRecognize which amendmen ts impact the European vigilance system\nInterpret the new guidelines that cover incidents involving devices that carry the CE mark and devi ces that do not carry the CE mark\nSubmit periodic summary reports of incidents to Competent Authorities.\n\n Who Will Benefit:\n\nAll level s of management and departmental representatives and those who desire a better understanding or a \"refresh\" overview\nRegulatory Affairs\n Clinical Affairs\nQuality and Compliance\nMarketing & Sales \nDistrib utors\nEngineering/Technical Services/Operations\nConsultants\n\n\n\n\ nDavid R. Dills, an independent Regulatory & Compliance Consultant wit h more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and com pliance background with Class I/II/III and IVD devices and managing an d handling activities within the global regulatory and compliance land scape.\n\nPrice: $245.00\n\nGlobalCompliancePanel\nNetZealous LLC, 16 1 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800- 447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http:// www.globalcompliancepanel.com\nRegistration Link\n\n\n\n\n\nFor more i nformation visit https://medtechiq.ning.com/events/edical-device-postm arketing-vigilance-reporting-update-and DTSTART;TZID=America/New_York:20130509T100000 DTEND;TZID=America/New_York:20130509T110000 CATEGORIES:webinar, healthcare, medical, device, pharmaceutical, clini cal LOCATION:Online Training WEBSITE:http://bit.ly/108vCQh URL:http://bit.ly/108vCQh CONTACT:8004479407 ORGANIZER:GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562011438?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR