JSM 2017 Online Program

Legend:
CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme

Keyword Search Criteria: Safety Monitoring returned 7 record(s)

Sunday, 07/30/2017

Statistical Innovations on Safety Analyzes
Shuai Yuan, Merck; William W Wang, Merck & Co Inc
2:05 PM

Statistical Monitoring of Safety via a Bayesian Predictive Approach
LiAn Lin; Greg Ball, Merck; William W Wang, Merck & Co Inc
2:20 PM

Tuesday, 08/01/2017

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

On Bayesian Safety Monitoring
Hal Li, Merck Research Laboratories; William Wang, Merck
11:20 AM

Wednesday, 08/02/2017

Aggregate Safety Monitoring for the FDA IND Safety Reporting Final Rule
Greg Ball, Merck

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

When to Alert a Safety Assessment Committee - Approaches and Examples
Brian Waterhouse
11:15 AM