The responsibilities for all stakeholders involved are set out in GVP Module XVI for Risk Minimisation . It is important to ensure that additional risk minimisation measures, including assessment of their effectiveness, do not introduce undue burden on the healthcare delivery system, the marketing authorisation holders, the regulators, and, most importantly, on the patients. The necessity to have a clearly defined objective in order to minimise risks and/or optimise the risk-benefit balance is becoming increasingly important.SMi's masterclass hosted by Oxon Epidemiology will provide delegates the opportunity to learn about risk minimisation studies, their implementation and evaluation in Europe from two EMA experts: a regulator from the EMA PRAC committee and a clinical Pharmacoepidemiologist at ENCePP.Why you should attend:Discuss your challenges in risk minimisationEvaluate effectiveness of planned and ongoing risk minimisationLearn from real-life case studies and exercisesAnalyse the principles of risk managementIncrease effective alignment of risk studies and regulatorsGain insights into the benefits of using an evidence-based toolkitSpeakers: Dr Nawab Qizilbash, Head, Geriatrician and Epidemiologist, Oxon Epidemiology Dr Sabine Straus, Member of the PharmacoVigilance Risk Assessment Committee (PRAC) of the EMAPrice: Standard Rate: £599.