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.
"Notes to Editors"
About the Masterclass leader:
Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
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):
For further information and the opportunity to register online please visit; www.smi-online.co.uk/
Alternatively, contact Cem Tuna on +44 207 827 6734 or by email firstname.lastname@example.org