Best practice for benefit-risk assessment for the new PSUR

Organization: SMi Group

Venue: Holiday Inn London Bloomsbury

Location: London, United Kingdom

Event Date/Time: Apr 09, 2013 / 8:30 am - (GMT) End Date/Time: Apr 09, 2013 / 5:30 pm - (GMT)
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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.  Email:  Tel: +44 (0) 20 7827 6736  URL:


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United Kingdom


SMi Group