Best practise for benefit risk assessment in the new PSUR*
09 Apr 2013 - 09 Apr 2013 - London, UK
The EMA expects MAHs to submit the new PSUR (from early 2013). This marks a paradigm shift. The PSUR will change from being a largely based on-line listings, narratives and simple sales-based incidence statistics to a benefit-risk assessment tool with a much more statistical and quantitative approach to adverse event data with the incorporation of efficacy (including patient-reported outcome) data. The master class will provide attendees with the essential skills to ultimately confront the newly revised and incorporated elements of benefit-risk analysis for the new PSUR in their company.