Advanced Workshop on Signal Detection & Medical Device Vigilance

Workshop Overview

Workshop Trainer: Dr. Graeme Ladds

This two-day course offers an updated and pragmatic view of the requirements for signal detection as mentioned within the legislation and its practical implementation. Signal analysis and determination also requires appraisal for all confirmed signals of the overall influence of such new signals on the benefit-risk profile of the product including and risk minimisation activities proposed as a result of identifying the new signal.

This course works as an excellent introduction for those wanting to understand the evolving safety profile of a product from the clinical and into the post marketing phase and the impact on labelling; safety education, Risk Management/Minimisation plans, updates in periodic reports including any events of special interest.

The second day of the course focuses on the recent updates and changes with Medical Device Vigilance and the enhanced safety requirements together with the changes that have happened with the UK not adopting the new EU Medical Device legislation and the impact on existing medical devices and new ones coming to market. The course will be interactive with a combination of course lectures, discussions, questions and solutions.