JSM 2017 Online Program

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

Keyword Search Criteria: FDA returned 11 record(s)

Sunday, 07/30/2017

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

Clusering functional data using projections
Aurore Delaigle, University of Melbourne; Peter Hall, University of Melbourne; Tung Pham, University of Melbourne
3:20 PM

Monday, 07/31/2017

FDA Draft Guidance on Multiple Endpoints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

An R Shiny Foundation for Standardized Clinical Review Tools
Jimmy Wong, FDA

Analytical Framework for Safety Assessment Committee (SAC) in Drug Development
Amit Bhattacharyya, ACI Clinical; Jonathan Seltzer, ACI Clinical
9:50 AM

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

FDA/Industry-Wide Recommended Analyzes and Displays: a Vision Within Reach
Sheryl Treichel, Amgen

Wearable Devices in Daily Activities and Clinical Trials
R. Lakshmi Vishnuvajjala, FDA/CDRH

Cerebrospinal Fluid Biomarker Signature in Alzheimer's Disease Genetic Association Landscape by Functional Linear Models.
Olga Vsevolozhskaya; Ilai Keren, Washington Department of Fish and Wildlife; David Fardo, University of Kentucky; Dmitri Zaykin, NIH/NIEHS
11:35 AM

Wednesday, 08/02/2017

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

CDISC Submissions and the Role of Statisticians
Chris Holland, Amgen
2:45 PM

JSM 2017 Online Program

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ASA Meetings Department

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