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

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)