AN INTRODUCTION TO POST MARKETING SURVEILLANCE AND THE EUROPEAN MEDICALDEVICE VIGILANCE SYSTEM 2011

INTRODUCTION

A manufacturer s responsibility for a medical device does not come to an end when the device is CE marked and sold on the market. The period after the sale is just as important as the pre-market approval stage. It is during this period that more can be learnt about a device and where the obligations lie with manufacturers to have an appropriate post market surveillance system in place. This one day practical workshop will introduce you to the concept of post market surveillance, what it is, how to implement it effectively and how to understand and interpret the regulatory requirements for your products. There will be ample time for case study exercises and group discussions throughout the day.

WHO SHOULD ATTEND

This meeting is appropriate for all those concerned with monitoring and managing the safety and performance aspects of medical devices during the post market phase. This is an introductory course and will therefore be particularly useful for personnel new to a regulatory role which involves post market surveillance, it will also be useful to clinical staff who have a desire to understand more about the vigilance procedures particularly in relation to management, monitoring and reporting of adverse incidents. It will also be applicable to those wishing to gain a better understanding of the post market surveillance and vigilance procedures in general, where it may be necessary to have some knowledge to be able to carry out their duties more effectively.

Programme to include:

• What is Post Market Surveillance (PMS)?
• Discover why PMS is necessary
• The regulations and guidelines, what are they and how should we apply them?
• Understand the purpose of a vigilance system
• Learn how to monitor, manage and report incidents
• Post market clinical studies; how should these be conducted and how should events be reported?

Please contact [email protected]if you wish to know more about this course.