Keyword Search
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CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme
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Keyword Search Criteria: safety returned 33 record(s)
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Sunday, 07/30/2017
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Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
Richard C. Zink, JMP Life Sciences, SAS Institute, Inc.
2:05 PM
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Statistical Innovations on Safety Analyzes
Shuai Yuan, Merck; William W Wang, Merck & Co Inc
2:05 PM
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Statistical Monitoring of Safety via a Bayesian Predictive Approach
LiAn Lin; Greg Ball, Merck; William W Wang, Merck & Co Inc
2:20 PM
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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
2:30 PM
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Leverage Real World Data to Support Drug Safety Surveillance: Cases Studies of the Applications
Xiaofeng Zhou, Pfizer Inc; Andrew Bate, Pfizer
4:45 PM
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Drug Safety and Comparative Effectiveness at Massive Scale
Yuxi Tian, David Geffen School of Medicine At UCLA; Marc A. Suchard, University of California, Los Angeles; Martijn Schuemie, Janssen Research and Development
5:05 PM
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Marginal Meta-Analysis for Combining Multiple Randomized Clinical Trails with Rare Events
Yun-Ju UMBC Cheng, UMBC; Yi Huang, UMBC; Elande Baro, FDA; Guoxing Soon, FDA
5:35 PM
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Monday, 07/31/2017
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Non-Inferiority Trials for Efficacy and Safety
Steve Snapinn, Amgen
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Modeling Excess Zeroes in an Integrated Analysis of Vaccine Safety
Roger Maansson, Pfizer Inc.; David Radley, Pfizer Inc.; Qin Jiang, Pfizer Inc.; Scott Patterson, Pfizer Inc.; Judith Absalon, Pfizer Inc.; John Perez, Pfizer Inc.
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Need for New Statistical Methods to Save Lives on Highways
Eric Donnell, The Pennsylvania State University; R. J. Porter, VHB; Larry Cook, University of Utah; Raghavan Srinivasan, University of North Carolina - Highway Safety Research Center; Joseph Kufera, University of Maryland
8:35 AM
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Data's Role in Motor Vehicle Traffic Safety
Terry Shelton, U.S. Department of Transportation
9:00 AM
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Inverse Probability of Treatment Weighted Estimator for Exposure Adjusted Incidence Rate Ratio for Rare Adverse Event in Pooled Studies Controlling for Confounding by Study
Hui Wang, Astrazeneca; Sudipta Bhattacharya, AstraZeneca
9:20 AM
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Analytical Framework for Safety Assessment Committee (SAC) in Drug Development
Amit Bhattacharyya, ACI Clinical; Jonathan Seltzer, ACI Clinical
9:50 AM
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Signal Detection from Large Drug Safety Databases
Ram Tiwari, FDA/CDER/OT/OB
11:05 AM
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Analyzes of Nighttime Seat Belt Usage Based on Gender, Vehicle Type, and Geography
Kwaku Boakye, University of Tennessee, Knoxville; Shashi Nambisan, University of Alabama; Mack Shelley, Iowa State University
11:35 AM
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Bayesian Analysis of Explosive Safety Scenarios
David Collins; Eric M. Heatwole, Los Alamos National Laboratory
2:35 PM
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Tuesday, 08/01/2017
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Integrating Data Science and Big Data Concepts and Machine Learning in Drug Safety
Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
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Discriminant Analysis (DA) Based Methods in Safety Evaluation
Angang Zhang, Merck; Richard Baumgartner, Merck; William W Wang, Merck & Co Inc
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Discriminant Analysis (DA) Based Methods in Safety Evaluation
Angang Zhang, Merck; Richard Baumgartner, Merck; William W Wang, Merck & Co Inc
9:15 AM
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Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology and Cross-Disciplinary Scientific Engagement
Greg Ball, Merck; Frank Rockhold, Retired; Janet Wittes, Statistics Collaborative, Inc. (SCI); Ana Szarfman, CDER, FDA; William W Wang, Merck & Co Inc
10:35 AM
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On Bayesian Safety Monitoring
Hal Li, Merck Research Laboratories; William Wang, Merck
11:20 AM
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A Selective Inference-Based Two-Stage Procedure for Clinical Safety Studies
Yalin Zhu, New Jersey Institute of Technology; Wenge Guo, New Jersey Institute of Technology
3:20 PM
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Wednesday, 08/02/2017
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Aggregate Safety Monitoring for the FDA IND Safety Reporting Final Rule
Greg Ball, Merck
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Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance
Kefei Zhou, Theravance Biopharma; Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
10:35 AM
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Generalized Random-Effects Linear Models to Examine Driver Safety
Ning Li, University of Washington; Linda Ng Boyle, University of Washington
10:50 AM
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Analysis of Clinical Trial Adverse Event Data
Michael Fries, CSL Behring; Judy X. Li, Regeneron Pharmaceuticals; Matilde Sanchez-Kam
10:55 AM
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Evaluating Safety Performance Measures for Motor Carriers Using Hierarchical Models
Xingwei Wu, University of Washington; Huizhong Guo; Linda Ng Boyle, University of Washington
11:05 AM
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When to Alert a Safety Assessment Committee - Approaches and Examples
Brian Waterhouse
11:15 AM
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WHY IS ROAD SAFETY BETTER UNDER DRIVING IMPAIRMENT DUE to BOTH MARIJUANA and ALCOHOL THAN EACH SEPARATELY? DATA ANALYTICS ANSWERS,Ramalingam Shanmugam1, Ram C. Tripathi2 and Karan
Ramalingam Shanmugam, Texas State University; Ram Tripathi, UTSA, Texas; Karan Singh, UT-Tyler
11:20 AM
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