This unique master class will provide attendees with an in depth insight into signal detection and will cover compliance with the new EU GVP legislation. This interactive session will explore implementation, quality and auditability of signal detection, as well as providing attendees with the opportunity to discuss case studies on implementing compliant statistical signal detection strategies.
Led by the experts at Oxon Epidemiology, this master class will act as the perfect forum for attendees to discuss and develop strategies in signal detection. Attendees will explore opportunities to apply signal detection and will understand real life practice of statistical signal detection and evaluation. With case studies on how other companies are implementing statistical signal detection this master class, co-located with SMi’s Benefit-Risk Assessment Master class on the 9th December, is not to be missed.
After the course participants will be able to:
• Appreciate the requirements of the new EU legislation (GVP) for signal detection
• Application of signal detection to the new PSUR
• How to make signal detection traceable and auditable
• Describe the role of statistical signal detection in the new GVP
• Understand the principles and practice of statistical signal detection & evaluation
• Learn how other companies implement statistical signal detection
• Discuss how to implement/optimise statistical signal detection strategies in your company for GVP
• Learn from real-life case studies and exercises
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.
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, until the takeover by MSD. She ensures that all safety aspects of OXON’s work for clients are compliant with current regulations and auditable.
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.