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557 * !
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Wed, 7/31/2019,
2:00 PM -
3:50 PM
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CC-108
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Data Monitoring Committees – the Multi-Disciplinary Approach to Drug Safety Assessment — Topic Contributed Papers
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Biopharmaceutical Section, International Indian Statistical Association, Section for Statistical Programmers and Analysts
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Organizer(s): Amit Bhattacharyya, Alexion Pharmaceuticals
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Chair(s): William (Bill) Wang, Merck Research Lab
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2:05 PM
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EMERGING CHANGES in DMC OVERSIGHT
Susan S. Ellenberg, University of Pennsylvania
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2:25 PM
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A Journey Through Guidelines for DMC in Addressing Evolving Paradigm Changes – What Really Matters
Estelle Russek-Cohen, FDA CDER
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2:45 PM
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The Perfect DMC – a Multi-Disciplinary Approach to Monitor Patient Safety:
Jonathan Seltzer, ACI Clinical
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3:05 PM
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Implementing Effective DMC Decision-Making in Complex Clinical Trial Designs
Paul Gallo, Novartis Pharmaceutical
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3:25 PM
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Are Interactive Graphics in a DMC Ready for Prime-Time, for Better Safety Reviews?
James Buchanan, Covilance LLC
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3:45 PM
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Floor Discussion
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