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Keyword Search Criteria: drug development returned 9 record(s)
Monday, 07/31/2017
Open-Source Programming in the Regulated Environment
Greg Valin, Amgen


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

Tuesday, 08/01/2017
Benefit-Risk Analysis in Medical Development
Shuai Yuan, Merck


Expert Prior Elicitations in Practice
Michael Sonksen, Eli Lilly and Company
2:25 PM

PRO-CTCAE in Oncology Clinical Trials: a U.S. Regulatory Perspective
Paul Kluetz, U.S. Food and Drug Administration
2:45 PM

Wednesday, 08/02/2017
Statistical Inference in the Era of Precision Medicine- the Essential Role of Statistics for Unmet Needs in Algorithm Refinement, Diagnostics Application and Drug Development
Ruixiao Lu, Genomic Health


A Case Study Exploration of MTPI and Proposed Methods to Expand to Combination Drug Development
Matthew Gribbin, MedImmune; Nairouz Elgeioushi, MedImmune
10:35 AM

Drug Development Planning and CDISC Standards from the Perspective of a Programmer/Analyst
Michael Carniello, Astellas Pharma
2:05 PM

Interplay Between Estimands and Missing Data in Clinical Trials
David Ohlssen, Novartis
2:05 PM

 
 
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