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

Activity Details

330 * ! Tue, 8/3/2010, 10:30 AM - 12:20 PM CC-122 (West)
Safety Signal Detection in a New Drug Development Program — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Guowen (Gordon) Sun, sanofi-aventis
Chair(s): Guowen (Gordon) Sun, sanofi-aventis
10:35 AM Meta-Analysis for Rare Adverse Event Data from Clinical Trials Brenda Crowe, Eli Lilly and Company
10:55 AM Real-Time Safety Assessment: A Sponsor's Approach on Tool Development to Facilitate the Assessment Christy Chuang-Stein, Pfizer Inc. ; Craig Hartford, Pfizer Inc. ; David M. Jones, Pfizer Inc. ; Janice Lamb, Pfizer Inc.
11:35 AM Prospective Safety Analysis Plans: Critical Elements and Principles George Rochester, FDA
11:55 AM Discussant: Susan Ellenberg, University of Pennsylvania School of Medicine
12:15 PM Floor Discussion

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