December 4-8, 2017 at Atlantic City, New Jersey
The 73rd Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA

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12/7/2016 (Wednesday) 1:30 PM - 4:30 PM

Session K: Regulatory statistics with some European perspectives

Prof. Franz König, Medical University of Vienna
Prof. Martin Posch, Medical University of Vienna
Dr. Frank Bretz, Novartis Pharma AG

Moderator: Ivan Chan
We start with an overview of the European regulatory system, explaining the main regulatory bodies (EMA, national agencies) and their working parties (CHMP, SAWP, PDCO, COMP, BSWP, MSWP, …). We also discuss regulatory procedures in Europe (such as scientific advice and protocol assistance) and the concept of seeking for qualification opinions of novel methodologies for medicine development. We illustrate these procedures with a review on scientific advice letters on adaptive designs and with the recent MCP-Mod qualification opinion, which marks the first, and to date the only clinical trial methodology formally endorsed by any regulatory agency. This discussion leads into an overview of European statistical guidance documents (Concept Papers, Reflection Papers, …) on statistical topics that have recently been published or are current under discussion. We complement the overview of the European regulatory system with an overview of the European industry associations and initiatives (EFPIA, EFSPI, PSI, IMI, …). Finally, we conclude this tutorial with a discussion of two scientific topics that are currently receiving considerable attention in Europe: the addendum to the ICH E9 guidance on choosing appropriate estimands and defining sensitivity analyses in clinical trials and data sharing and publication of clinical trial data.

Franz König is Associate Professor at the Section of Medical Statistics at the Medical University of Vienna, Austria. He regularly serves as member of ethics committees and DSMBs. From 2008 till 2010 he was seconded to the European Medicines Agency as statistical expert. His main research interests are multiple testing and adaptive designs. See .

Martin Posch is professor of Medical Statistics at the Medical University of Vienna, Austria, and head of the Center for Medical Statistics, Informatics and Intelligent Systems. From 2011-2012 he worked as statistical expert at the European Medicines Agency. His research interests are group sequential trials, adaptive designs and multiple testing. See

Dr. Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is an Adjunct Professor at the Hannover Medical School, the Shanghai University of Finance and Economics and the Medical University of Vienna.

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