Understanding and Implementing the EU Vigilance System 2016

Topics

• The role of MEDDEV documents in the EU system
• An overview of the EU Vigilance System
• The timing of adverse event reports, including their classification
• The conditions that require an EU adverse event report
• Trending of complaints and required reporting after recognizing a "signal"
• Developing Periodic Summary Reports to help reduce the quantity of reports
• The two elements of recalls - the Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)

Who should Attend

Attendees from:

• Management Representatives
• Regulatory Managers
• Compliance Managers
• Quality Managers
• Audit Managers
• Notified Body Liaison
• Complaint and Incident Specialists