Hear and receive guidance to the latest additions to the new PSUR report

PRLog (Press Release) - Feb. 15, 2013 - As a result from the upcoming changes in 2013 the PSUR guidelines, the approach to all PSURs will be affected, in particular EMA will be 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.

Under the guidance of industry experts Nawab Qizilbash, Marta Mariño & Andrew Maguire, OXON Epidemiology, SMi's masterclass will explore the purpose and structure of benefit risk analysis of the new PSUR. This session will enable delegates to work with experts in quantitative risk based analysis andpharmacovigilance to help plan and submit a PSUR with an appropriate benefit-risk assessment.

Delegates attending will be given insights to:
• Understand the concepts of the new PSUR
• Learn best practice and details of benefit-risk analysis for the new PSUR
• Avoid common pitfalls of poor benefit risk analysis
• Discover new skills to ensure compliant benefit-risk assessment for the new PSUR
• Identify approaches for old and new drugs from real life case studies.

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"Notes to Editors"

About the Masterclass leader:
Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) is Head & Principal Consultant at OXON Epidemiology and; Honorary Senior Lecturer in Epidemiology,
London School of Hygiene & Tropical Medicine; Honorary Consultant Geriatrician,
Madrid, Member of Green-Templeton College, Oxford University.
Co-author of x5 Lancet, x1 JAMA and x3 BMJ publications in epidemiology,
trials and meta-analysis Chief editor of the internationally
authored textbook: ´Evidence-based Dementia Practice´ published by
Blackwells, Oxford. Nawab was formerly: Director of Epidemiology &
EBM at GlaxoSmithKline (1997-2005); Honorary Consultant Physician, Radcliffe
Infirmary, Oxford; and chief editor of the Cochrane Dementia Group.

Andrew Maguire BSc MSc FSS is Director of Global Epidemiology & Database Services at OXON. Andy is a statistical epidemiologist who has specialised in databases and benefit-risk analysis methodology. He has worked in the epidemiology departments of Pharmacia and Pfizer. He has worked at GPRD and THIN in the UK. Andy’s last post was as Director of Epidemiology and Database Analytics for Europe for a US multinational scientific service provider. In this role he lead a group of epidemiologists and programmers undertaking real world pharmacoepidemiological research using medical databases, epidemiological modelling as well as epidemiological and burden of disease support for the pharmaceutical sector. He is located in London.

Marta Mariño BSc is Director of Pharmacovigilance at OXON, and
brings the experience of being Head of Pharmacovigilance at
Schering-Plough, Spain from 1995-2010.

About OXON Epidemiology
OXON Epidemiology is a European full-service CRO with Asian and Latin American reach that specialises in ´real word data´(www.oxonepi.com): Epidemiology (field and database studies and patient registries),Safety (statistical signal analysis, benefit-risk analysis, risk management), Health economics, Patient-reported outcomes, Meta-analysis, Decision analysis and Evidence strategy for pre-and post-approval products. OXON provides the highest standards: leading an initiative on data integration with EMA regulators and academic pharmacoepidemiologists as an ENCePP centre; OXON staff have co-authored (x6) Lancet, (x1) JAMA and (x3) BMJ publications; an academic affiliation with the London School of Hygiene & Topical Medicine; and has world renowned academic consultants in Statistics, Safety and Patient-reported outcomes. A 4-year strategic alliance with a middle-tier global CRO provides operational support for pan-European, Asian and Latin American projects.

For further information and the opportunity to register online please visit; www.smi-online.co.uk/bestpractice-psur9.asp

Alternatively, contact Cem Tuna on +44 207 827 6734 or by email ctuna@smi-online.co.uk