Biotech China 2014
5th Annual FDA/DIA Statistics Forum
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road North Bethesda, MD 20852
Bethesda, Maryland
   An Open Forum to Discuss Important Statistical
   Issues Associated with the Development and Review of Therapeutic Drugs
   and Biologics

   Event Code 11008

Schedule of Presentations:

Monday, April 11, 2011
08:45:00 WELCOME AND OPENING REMARKS Barry H. Schwab, Stephen E. Wilson
09:00:00 KEYNOTE ADDRESSES Nancy L Geller, Jesse L. Goodman, Robert T. O'Neill
11:00:00 SESSION 1 | Report from the NAS Panel on Missing Data | Overview and Recommendations David Ohlssen, Dionne Price
11:15:00 Session Description Jay P. Siegel, Thomas J. Permutt , Roderick J Little
13:30:00 SESSION 2 | Feedback and Comments on the NAS Missing Data Panel Report | Regulatory and Industry Views Camille Logue Orman, Gouxing Soon
14:00:00 Session Description Douglas C. Throckmorton, James Henry Roger, David J. Wright , Karen Higgins
15:30:00 SESSION 3 | Panel Discussion on the NAS Missing Data Panel Report Jose C. Pinheiro, Joan K Buenconsejo
16:00:00 Session Description David J. Wright , Douglas C. Throckmorton, Jay P. Siegel, James Henry Roger, Thomas J. Permutt , Roderick J Little, Michael Kenward, Karen Higgins
Tuesday, April 12, 2011
08:30:00 SESSION 4 | Bayesian Applications in the Device Industry, CDRH Guidance, and Bayesian Approaches Telba Irony
09:00:00 Session Description Nitin R Patel, Telba Irony, Gregory Campbell
10:30:00 SESSION 5 | Bayesian Applications in the Pharmaceutical and Biotech Industries Ram Tiwari
11:00:00 Session Description Ram Tiwari, James Stamey, Beat Neuenschwander
13:15:00 SESSION 6 | Bayesian Applications: Panel Discussion Ram Tiwari
14:00:00 Session Description Ram Tiwari, James Stamey, Nitin R Patel, Robert T. O'Neill, Beat Neuenschwander, Telba Irony, Gregory Campbell
15:00:00 SESSION 7 | Data Monitoring Committee Experiences in Multi-Regional Clinical Trials Sue-Jane Wang , Bruce Binkowitz
16:00:00 Session Description Jay Herson , Janet Wittes
Wednesday, April 13, 2011
08:30:00 SESSION 8 | Meta-Analysis | Efficacy and Safety Aloka Chakravarty , Jerald S. Schindler
09:30:00 Session Description Scott H Korn, Sanjib Basu, George Rochester
10:30:00 SESSION 9 | Risk and Benefit Assessment Approaches Ralph B. D'Agostino, Christy Chuang-Stein , Baruch Fischhoff
13:00:00 SESSION 10 | Clinical Case Studies
14:30:00 SESSION 11 | Panel and Floor Discussion Christy Chuang-Stein , Robert T. O'Neill, Baruch Fischhoff , Ralph B. D'Agostino
4th Annual Pharma R&D Asia Congress
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