Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada 2012 is a webinar that covers topics such as:
- 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
Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada 2012 brings together 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)
