Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
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Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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