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Welcome Remarks and Session 1: Challenges with Global Development and Satisfying Regulatory Requirements
Session Chair(s)
Mouna Akacha, PhD
Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland
Aloka Chakravarty, PhD
Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
In this session we will provide an overview of the changes in the regulatory landscape driven by the development of various ICH guidance documents (E8, E9, E11, E17, E19, E20). The key statistical challenges and opportunities that are in scope of the ICH guidelines will be discussed. Furthermore, the link and the overlap of some of the guidelines will be highlighted and the role of the Bayesian framework in these developments will be discussed.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Recognize the various ICH documents and their impact on drug development
- Identify issues and challenges in global drug development
- Engage in meaningful discussions with multidisciplinary team on estimands, Bayesian framework and other key statistical concepts
Speaker(s)
Statistical Issues in ICH Guidances: Beyond E9
Aloka Chakravarty, PhD
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Director, Data Analytics
Panelist
Mark Levenson, PhD
FDA, United States
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
Panelist
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Panelist
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
Panelist
Frank Bretz, PhD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Panelist
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
Panelist
Greg Ball, PhD
ASAPprocess, United States
Safety Data Scientist
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