EFSPI MHRA 2010 meeting flyer
Joint EFSPI-MHRA meeting, London, 29th and 30th March 2010 Statistics at the frontier of drug development The meeting intended to provide a unique opportunity for discussion amongst industry, regulatory and academic scientists.
Finding independence graphs for clinical trial adverse event data - Joe Whittaker and Lucy Bradshaw (Lancaster University) Harry Southworth (AstraZeneca)
If You Are Serious About Benefit:Risk Assessment - Christy Chuang-Stein (Pfizer)
A regulator’s view of end of Phase II decision making and phase II studies - Dr David Wright (MHRA)
Applied Bayesian Approaches in Safety and Pharmacovigilance - Andy Grieve (King‟s College London)
Promoting high-quality and informative exploratory development: obstacles and aids - Michael O’Kelly (Quintiles)
Quantitative benefit-risk assessment: An analytical framework for a shared understanding of the effects of medicines - Mike Colopy & Patrick Ryan (GSK)
Some recent experiences with novel - Ekkehard Glimm (Novartis)
Modelling for decision making in clinical programs - Rolf Burghaus (Bayer Schering Pharma)
Quantification and evaluation of risk at the time of licensing - Dr David Wright (MHRA)
Meta-analyses of controlled clinical trials for rare AEs - Kevin Carroll (AstraZeneca)
Adaptive designs with subgroup selection in Oncology - Werner Brannath (MUW Vienna)