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DTSTART:19700308T020000
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BEGIN:VEVENT
UID:2140535:Event:68830
DTSTAMP:20260409T035021Z
SUMMARY:Webinar on Implementing Medical Device Global Adverse Event Re
 porting Systems
DESCRIPTION:Description :\nThe purpose of this session is to get you a
 cquainted with adverse event reporting requirements and systems in EU,
  Canada and US. The obligation of Medical Device Manufacturers doesnâ€
 ™t end after obtaining a clearance, approval, registration, listings o
 r certificates. They are required to report adverse events to the heal
 th authorities (e.g., Competent Authorities, Health Canada and US FDA)
  wherever applicable. To achieve compliance and remain compliant with 
 adverse event reporting requirements, it is imperative that medical de
 vice manufacturers understand what requirements apply and how to meet 
 those prescribed requirements.\nIn this conference, our presenter will
  walk you through the applicable adverse event reporting requirements 
 and help you understand them clearly as well as explain how to remain 
 in conformity with the requirements in EU, Canada and US. Going furthe
 r with the session, Dr. Lim will help you change your way of planning,
  developing, implementing and following your relevant and applicable p
 rocesses so that you do it efficiently and effectively. In this confer
 ence, you will be able to become familiar with Global Adverse Event Re
 porting (AER) systems and also ensure if your current AER system are c
 ompliant enough.\nAreas Covered in the Session :\nApplicable and relev
 ant laws and regulations in EU, Canada and US\nDefinitions\nMedical de
 vice adverse event reporting requirements in EU, Canada and US\nMedica
 l device vigilance system during the post-production phase in EU\nMand
 atory medical device problem reporting requirements in Canada\nMandato
 ry medical device reporting requirements in US\nReview of actual repor
 ting forms in EU, Canada and US\nApplicable and relevant guidance docu
 ments\nCommon mistakes and how to prevent them\nBest practices\nPASS-I
 T solutions\nConclusion\nWho Will Benefit:\nCEOs\nVPs\nCompliance Offi
 cers\nAttorneys\nRegulatory Affairs\nClinical Affairs\nQuality Assuran
 ce\nResearch & Development\nConsultants\nContractors/Subcontractors\nA
 nyone Interested in the FDA inspection Process\n\nFor more information
  visit https://medtechiq.ning.com/events/webinar-on-implementing-medic
 al-device-global-adverse-event
DTSTART;TZID=America/New_York:20160317T130000
DTEND;TZID=America/New_York:20160317T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1782
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1782
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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