JSM 2017 Online Program

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

Keyword Search Criteria: guidance 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

Multi-Regional Clinical Trials and the ICH E17 Draft Guidance
Bruce Binkowitz, Shionogi, Inc.; Aloka Chakravarty, US FDA, CDER; Steve Snapinn, Amgen; Romi Singh, Pfizer
4:05 PM

Monday, 07/31/2017

FDA Draft Guidance on Multiple Endpoints
Kate Liu, Amgen, Inc.

Sample Size Determination for Number of Patient Interviews When Developing a PRO Using Qualitative Research Based on the FDA PRO Guidance
Chris Barker, Statistical Planning and Analysis Services, Inc.
2:50 PM

Tuesday, 08/01/2017

Achieving Consensus on Guidance for Specifying the Target Difference in a RCT Sample Size Calculation - DELTA2 Project
William Sones, University of Oxford; Jonathan Cook, University of Oxford
10:55 AM

New DELTA2 Guidance on Specifying the Target Difference in a RCT Sample Size Calculation
Jonathan Cook, University of Oxford
11:35 AM

Wednesday, 08/02/2017

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