All day
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EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE
(Course / Training / Workshop)
WHO SHOULD ATTEND
This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community.
PREPARATION
It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference.
Chairman:
Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical
With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry
BENEFITS IN ATTENDING:
■ Understand the EU Vigilance Process
■ Realise the Legal Obligations
■ Know How to Handle Field Safety Corrective Actions (FSCAs)
■ Discover What a Notified Body Expects from an Audit on PMS Systems
■ Discuss Risk Management
■ Hear How Various Member States Handle Vigilance Reports
■ Clarify the Role of Notified Bodies in Vigilance and FSCAs
■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Event Website : EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE
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44 1483 730071
