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. Under the guidance of PharSafer, SMi's masterclass will 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. For those involved in the analysis of safety data this will provide insight into both what the expectations of the new legislation are as well as practical approaches to performing such activities.Essential whether a generic or innovator Company. This one off Masterclass will be a must attend for specialists within the following areas of Drug Safety:Pharmacovigilance Team LeaderDrug Safety OfficerGlobal Drug Safety OfficerPharmacogilance ManagerHead of Safety and PharmacovigilancePharmacovigilance ConsultantsInternational PV auditorsSenior Safety SpecialistQPPV personnelRegulatory affairs AssociatesRegulatory Affairs ManagerLead Safety ScientistContact Fateja Begum Tel: +44 (0) 20 7827 6184