Course not currently available
EC Medical Device Vigilance System and Post Marketing Surveillance
Short course
In The Rembrandt Hotel, London ()
Description
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Type
Short course
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Level
Beginner
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Duration
2 Days
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. Suitable for: 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.
Reviews
Teachers and trainers (1)
Janette Benaddi
Chief Executive Officer, Medvance
Course programme
BENEFITS IN ATTENDING:
- Gain an in depth understanding of the EU Vigilance Process
- Practice the reporting rules with real examples
- Comprehend the legal obligations
- Be aware of expectations from Authorities in Field Safety Corrective Actions (FSCA)
- Comprehend what a Notified Body expects from an Audit on PMS Systems
- Understand the importance of the Risk Management Process Hear how various member states handle vigilance reports
- Clarify the role of Notified Bodies in Vigilance
- Keep abreast of future developments in PMS and Vigilance
Additional information
Contact person: Leigh White
EC Medical Device Vigilance System and Post Marketing Surveillance