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Quantitative Benefit Risk Assessment for the new PSUR and Risk Minimisation

Quantitative Benefit Risk Assessment for the new PSUR and Risk Minimisation
SMi is proud to announce that OXON Epidemiology Ltd will be hosting the Quantitative Benefit Risk Assessment for the new PSUR and Risk Minimisation masterclass taking place on the 2nd December 2014 in Central London 2014-08-20 13:33:41
This full-day Masterclass will provide attendees with the necessary exposure to approach the elements of benefit-risk analysis for the new PSUR in their company for new and old drugs, and approaches to evaluate the positive and negative effects of risk minimisation measures.

The EMA expects MAHs to submit the new PSUR (PBRER) which marks a paradigm shift. The PSUR will change from being largely a document based online listings, narratives and simple sales-based incidence statistics to a benefit-risk tool with a much more statistical and quantitative approach to adverse event data, and including the incorporation of efficacy data. Risk minimisation measures have negative as well as positive consequences and these should be evaluated.

Masterclass leaders include:
- Andrew Maguire, Director of Global Epidemiology & Database Services at OXON Epidemiology’s Centre for Real World Secondary Data, London
- Nawab Qizilbash, Clinical Epidemiologist & Head at OXON Epidemiology
- Ignacio Mendez, Director of HEAOR & Field Analytics at OXON Epidemiology’s Centre for Real World Field Studies, Madrid

The masterclass will aim to provide attendees with:
- The requirements of the European GVP legislation for the New PSUR
- The concepts behind quantitative BRA and why and when quantification is necessary
- The process for undertaking BRA and the evidence and data requirements
- A description of the role of quantitative models in BRA and understand regulatory expectations including the current opinion of the European working groups
- The methodological options available and their pros and cons
- The principles and practice of statistical BRA including the advantages and disadvantages of the principal methods
- A forum to discuss how to implement/optimise BRA for the new PSUR in your company for old and new products, and learn what other companies are implementing
- Approaches to evaluate the negative and positive effects of risk minimisation measures

For a conference programme visit:
For more information contact: Sajid Goraya on +44 (0) 207 827 6148 or email


About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries. More information can be found at

About OXON Epidemiology Ltd:
OXON is a consultancy and CRO based in London and Madrid that specialises in ´real word data ( Epidemiology (field and database studies and patient registries), Safety (PASS studies, statistical signal analysis, benefit-risk analysis, risk management), HEOR, Meta-analysis, development of concept protocols, and Evidence strategy for pre-and post-approval products. OXON provides the highest standards: an ENCePP centre of the European Medicines Agency with: a nominated ‘EMA Expert’, membership of the Steering, Multi-data Source and HTA Groups, and Chair of the Data Integration Group; co-authors of (x6) Lancets; an academic affiliation with the London School of Hygiene & Topical Medicine; world renowned consultants with EMA and FDA experience: medical statistician, Professor Stuart Pocock. A 5-year alliance with the 10th largest global CRO provides operational support for pan-European, Asian and Latin American projects.

Press Information
SMi Group Ltd
2nd Floor South, Harling House
47-51 Great Suffolk Street
United Kingdom

Teri Arri
Marketing Executive
+44 (0) 20 7827 6162

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Daniel Lee

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