Best practice for benefit-risk assessment for the new PSUR

Date: 09-Apr-13 to 09-Apr-13
Location: Holiday Inn Bloomsbury / London / United Kingdom
Category: Healthcare & Pharmaceuticals Conferences & Trade Fairs

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: jcollins@smi-online.co.uk

Tel: +44 (0) 20 7827 6736

URL: www.smi-online.co.uk/bestpractice-psur6.asp

Visitors

periodic, safety, user, report, PSUR, benefit-risk, assessment, clinical efficiency data, benefit-risk models, statistical signal detection, patient reported outcome

Exhibitors

periodic, safety, user, report, PSUR, benefit-risk, assessment, clinical efficiency data, benefit-risk models, statistical signal detection, patient reported outcome

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