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JSM 2011 Sessions on Medical Devices

FDA. Academia. Industry. JSM 2011 Sessions on Medical Devices. 1. Good Statistical Practice Organizer #1: Jianxiong Chu, FDA/CDRH Organizer #2: Xiaolu Su, Abbott Vascular Chair: Roseann White, Abbott Vascular Session #: 19 Time: 2:00 PM Sun July 31 Room: CC-B215

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JSM 2011 Sessions on Medical Devices

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  1. FDA Academia Industry JSM 2011 Sessions onMedical Devices 1. Good Statistical Practice Organizer #1: Jianxiong Chu, FDA/CDRH Organizer #2: Xiaolu Su, Abbott Vascular Chair:Roseann White, Abbott Vascular Session #: 19 Time: 2:00 PM Sun July 31 Room: CC-B215 2. Evaluation of Monitoring, Diagnostic, and Placement Guidance Devices Co-Organizer #1: Meijuan Li, FDA/CDRH Co-Organizer #2: Vandana Mukhi, FDA/CDRH Chair: Estelle Russek-Cohen, FDA Session #: 66 Time: 4:00 PM Sun July 31 Room: CC-D237 3. Non-inferiority Trial Design Issues for Medical Devices Co-Organizer #1: Heng Li, FDA/CDRH Co-Organizer #2: Terry Liao, Boston Scientific Corporation Chair: Terri Johnson, FDA/CDRH Session #: 116 Time: 8:30 AM Mon Aug 1 Room: CC-C225/226

  2. Industry Academia FDA JSM 2011 Sessions onMedical Devices 4. Statistical Considerations for the Evaluation of Diagnostic Devices and Biomarkers Organizer: Shanti Gomatam, FDA/CDRH Chair:Shanti Gomatam, FDA/CDRH Session #: 457 Time: 8:30 AM Wed Aug 3 Room: CC-C220 5. Statistical Planning and Data Analysis in Medical Device Trials Organizer #1: Caiyan Li, FDA/CDRH Organizer #2: Vivek Pradhan, Boston Scientific Corporation Chair: Chaya Moskowitz, Memorial Sloan-Kettering Cancer Center Session #: 500 Time: 10:30 AM Wed Aug 3 Room: CC-D239 6. Methods to Address Rare Events, Repeat Events, and Regulatory Requirements Organizer #1: Jin Wang, Abbott Vascular Organizer #2:Yu Audrey Zhao, FDA/CDRH Chair: Theodore Lystig, Medtronic Inc. Session #: 565 Time 2:00 PM Wed Aug 3 Room: CC-D235

  3. Industry FDA Academia JSM 2011 Sessions onMedical Devices 7. Application of Bayesian Statistics in Medical Device Trials: Design and Analysis Co-Organizer #1: Martin Ho, FDA/CDRH Co-Organizer #2: Huyuan Yang, Boston Scientific Corporation Chair: Peter Lam, Boston Scientific Corporation Session #: 611 Time: 8:30 AM Thu Aug 4 Room: CC-D237

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