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Keyword Search Criteria: safety returned 31 record(s)
Sunday, 07/29/2018
Graphical and Quantitative Literacy: Empowerment Begins with Naming and Describing What We Do
Susan Duke, FDA
2:45 PM

Q-Value and Its Application in Dynamic Safety Monitoring
Hal Li, Merck Research Laboratories; William Wang, Merck Research Laboratories
4:20 PM

Risk Prediction Through Temporal Phenotyping and Incorporation of MedDRA Information
Yong Chen, University of Pennsylvania; Rui Duan, University of Pennsylvania
5:20 PM

Monday, 07/30/2018
Standard Analyses and Displays for Common Clinical Trial Data: An Industry-Wide Initiative
Mercidita Navarro, Genentech


The Role of Real World Evidence in a Regulatory Environment: Focus on Safety
Estelle Russek-Cohen, US FDA CDER
8:35 AM

Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights
Olga Marchenko, Bayer
8:55 AM

Uncertainty Quantification of Injury Risk Measures
Dorin Drignei, Oakland University
11:35 AM

Outcomes of Suicide Risk Assessment and Safety Planning in a Longitudinal Mixed Mode Survey of Patients with Complex Psychiatric Disorders
Danna Moore, Washington State University-Social & Economic Science Research Center; John Fortney, University of Washington, School of Medicine; Dan Vakoch, Washington State Univesity-Social and Economic Sciences Research Center
3:25 PM

Tuesday, 07/31/2018
Safety Data Presentations in USPIs: Methodological Considerations
Adam Boyd, Array BioPharma Inc; Michael Pickard, Array BioPharma Inc


Outcomes of Suicide Risk Assessment and Safety Planning in a Longitudinal Mixed Mode Survey of Patients with Complex Psychiatric Disorders
Danna Moore, Washington State University-Social & Economic Science Research Center; John Fortney, University of Washington, School of Medicine; Dan Vakoch, Washington State Univesity-Social and Economic Sciences Research Center


Quantitative Regulatory Landscape
Lothar Tremmel, CSL Behring
8:35 AM

Going from the Program Safety Analysis Plan to the Aggregate Safety Analysis Plan
Barbara Hendrickson, AbbVie
8:55 AM

Specific Safety Monitoring Tools and How This Will Benefit Drug Safety
James Buchanan, Covilance LLC
9:15 AM

Using Survival Analysis to Address Attrition and Vacancy Rates at the Food Safety and Inspection Service
Sarah McMillan, Food Safety and Inspection Service / USDA; Anna Frey, Food Safety and Inspection Service / USDA
9:20 AM

Safety Analysis of Clinical Trials in NDA Submissions
Linyun Zhou, Takeda Global Research & Development
10:05 AM

A Note on Phase II Single-Arm Two-Stage Designs for Safety
Seongho Kim, Wayne State University; Weng Kee Wong, UCLA
10:50 AM

Unexpected Safety Signals in Dose Escalation Process
Chunzhang Wu, Astellas Pharma Global Development, Inc.
10:50 AM

Monitoring Vaccine Safety by Studying Temporal Trend of Adverse Events Using VAERS
Jing Huang, University of Pennsylvania; Yi Cai, Pieces Technology; Jingcheng Du, University of Texas Health Science Center; Ruosha Li, University of Texas School of Public Health; Susan S Ellenberg, University of Pennsylvania; Sean Hennessy, University of Pennsylvania; Cui Tao, University of Texas Health Science Center; Yong Chen, University of Pennsylvania
11:35 AM

Bayesian Analysis of Multivariate Crash Counts Using Copulas
Eun Sug Park, Texas A&M Transportation Institute; Man-Suk Oh, Ewha Womans University; Rosy Oh, Ewha Womans University; Jae Youn Ahn, Ewha Womans University
2:05 PM

Helicopter Safety Assessment in the Gulf of Mexico
Nastaran Coleman, Federal Aviation Administration
2:20 PM

Development of a Processed Cheese Food Safety Model Using a Response Surface Design and Parametric Survival Modeling
Francis Rossi, PepsiCo
2:45 PM

Wednesday, 08/01/2018
Model Driving Risk Through Naturalistic Driving Studies
Feng Guo, Virginia Tech
8:35 AM

Difference-In-Differences Versus Empirical Bayes for Causal Inference in Traffic Safety Research
Fan Li, Duke University
8:55 AM

Applying Item Response Theory Models to Highway Safety
Donald Hedeker, University of Chicago; Joel Greenhouse, CMU; Linda Ng Boyle, University of Washington
10:35 AM

Adaptive Dose Finding in Oncology Phase I-II Studies with Consideration of Tolerability and Efficacy
Rachael Liu, Takeda Pharmaceuticals ; Ling Wang, Takeda; David Sinclair, Google; Jianchang Lin, Takeda Pharmaceuticals
11:35 AM

Handling Missing Not at Random Data for Safety Endpoint in the Multiple Dose Titration Clinical Pharmacology Trial
Li Fan, Merck; Tian Zhao, Merck; Patrick Larson, Merck
3:20 PM

Thursday, 08/02/2018
Beware On-Treatment Safety Analysis
Janet Wittes, Statistics Collaborative; Fred Yang, Innomed Consulting
8:35 AM

The Likelihood Principle and Its Application to Aggregate Safety Monitoring
LiAn Lin; Bill Wang, Merck
8:55 AM

Visual Analytics to Assess Reasonable Possibility: Using DILI as an Example
Kefei Zhou, Theravance Biopharma; Melvin Munsaka, AbbVie, Inc.; Krishan P. Singh, GlaxoSmithKline
9:15 AM

Practical Considerations in Planning and Implementing Aggregate Safety Monitoring
Bill Wang, Merck
9:35 AM

A Bayesian Approach to Sequential Analysis in Post-Licensure Vaccine Safety Surveillance
Rongxia Li, Centers for Disease Control and Prevention
11:35 AM