Upcoming changes from 2013 will lead to the EMA expecting MAHs to submit the new PSUR. This marks a paradigm shift as the document will change from being largely based from online listings, narratives and simple sales-based statistics to a benefit-risk tool, aiming to provide a more focused, statistical and quantitative approach to adverse event information incorporating efficacy data. This full-day course led by the expertise of the Oxon Epidemiology Team will full prepare you to deal with the challenges of developing a benefit-risk analysis for the new PSUR and to understand the structure of benefit-risk analysis in this new paradigm. Attending this timely, interactive session will present attendees with the opportunity to work with experts in quantitative benefit-risk analysis and pharmacovigilance to plan an effective benefit-risk analysis and PSUR. Tel: +44 (0) 20 7827 6736