Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| 46 * ! | Sun, 8/3/2014, 4:00 PM - 5:50 PM | CC-258A | |
| Data-Monitoring Committees: Do They Have Role in Post-Marketing Approval Commitments? — Invited Papers | |||
| Biopharmaceutical Section , Section on Medical Devices and Diagnostics , Scientific and Public Affairs Advisory Committee | |||
| Organizer(s): Vipin Arora, Eli Lilly and Company | |||
| Chair(s): Stephen E. Wilson, FDA/CDER | |||
| 4:05 PM | Post Marketing Commitments: Study Designs and Their Implications for DMCs — Susan S. Ellenberg, University of Pennsylvania | ||
| 4:30 PM | DMS's Role When Post-Marketing Commitment Study Is Unlikely to Be Completed — Janet Wittes, Statistics Collaborative | ||
| 4:55 PM | Data Monitoring Committee Oversight of Open Label Studies — Marian Fisher, University of Wisconsin-Madison ; Kevin Buhr, University of Wisconsin-Madison | ||
| 5:20 PM | Discussant: Gary Koch, University of North Carolina at Chapel Hill | ||
| 5:45 PM | Floor Discussion | ||
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