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
Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada 2012 - 06 Mar 2012, Webinar (25969)
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