The aim of the class is to look at how the safety signal process leads into labelling changes and also risk management and minimisation activities in relation to the new EU legislation.
This should provide insight into what the levels of expectation there are within Companies to conduct safety review, what level is required, and how to assess open signals and closed signals (which will appear in the PBRER/DSUR) and then how that would be transferred into labelling and possible activities to reduce or eradicate such events by ensuring safety measures are applied to ensure patient safety.
From: December 04, 2013 08:30
To: December 04, 2013 12:00
Holiday Inn Bloomsbury, Coram Street, WC1N 1HT, London, United Kingdom