Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada 2012

  • 06 Mar 2012
  • Webinar

Description

Topics
  • Systematic and integrative (SI) review of regulations and law governing an adverse event reporting in the US, EU and Canada
  • Current, accurate, and complete (CAC) information on adverse event reporting
  • GHTF guidance(s)
  • CFR Part 820 and ISO 13485
  • EU Risk Management
  • EU Directives and Guidelines
  • ISO 14155
  • US FDA Reporting
  • Global guidance for adverse event reporting for medical devices
  • ISO 14971
Who should Attend

Attendees from the global medical device industry including:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Complaint handling personnel
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
  • Product and development (associates, scientists, managers,directors and VPs)
  • Research and development (associates, scientists, managers,directors and VPs)
  • Site managers, and consultants
  • Marketing (associates, specialists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers,directors and VPs)
  • Contract manufacturing organization (associates, scientists,managers, directors and VPs)
  • Contractors and subcontractors
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)

Past Events

Important

Please, check "Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device

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