This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Activity Details

328 * Tue, 8/3/2010, 10:30 AM - 12:20 PM CC-215 (West)
Meta-Analysis Related to Regulatory Issues: The FDA Guidance Document for Diabetes and Cardiovascular Risk — Topic Contributed Papers
Biopharmaceutical Section , ENAR , Health Policy Statistics Section
Organizer(s): Joan Buenconsejo, FDA
Chair(s): Andreas Brueckner, Bayer Schering Pharma
10:35 AM Evaluating Cardiovascular Risk in Diabetes Clinical Trials: Lessons Learned from Saxagliptin J Mark Donovan, Bristol-Myers Squibb
10:55 AM Multiplicity Issues in Meta-Analyses to Rule Out an Unacceptable Cardiovascular Risk Stefan Hantel, Boehringer Ingelheim Pharmaceuticals, Inc.
11:15 AM Evaluating Cardiovascular Risk in Diabetes Clinical Trials: An FDA Statistician's Perspective Jon Todd Sahlroot, FDA
11:35 AM Micro-Macro; FDA-EMA: On Developing Diabetes Drugs Janet Wittes, Statistics Collaborative, Inc.
11:55 AM Discussant: Steve Snappin, Amgen Inc.
12:15 PM Floor Discussion

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