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Activity Details

4 * ! Sun, 7/30/2017, 2:00 PM - 3:50 PM CC-310
Safety Evaluation, Data Sources, and Statistical Strategies: Transforming Information into Evidence — Invited Papers
ENAR
Organizer(s): Olga Marchenko, QuintilesIMS
Chair(s): Matilde Sanchez-Kam
2:05 PM Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
2:30 PM Transforming Real World Data into Evidence — Estelle Russek-Cohen, U.S. Food and Drug Administration ; Mark Levenson, FDA ; Qi Jiang, Amgen Inc. ; Richard C. Zink, JMP Life Sciences, SAS Institute, Inc. ; Michelle Krukas, QuintilesIMS ; Olga Marchenko, QuintilesIMS
2:55 PM Healthcare Data and Tools for Post-Market Drug Safety Mark Levenson, FDA
3:20 PM Discussant: Qi Jiang, Amgen Inc.
3:40 PM Floor Discussion
 
 
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