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Virtual Event

27 may 2020 10:45 a.m. - 29 may 2020 3:30 p.m.

(US Eastern Standard Time)

Fort Washington, PA 19034

DIA/FDA Biostatistics Industry and Regulator Forum

Welcome Remarks and Session 1: Challenges with Global Development and Satisfying Regulatory Requirements

Session Chair(s)

Mouna  Akacha, PhD

Mouna Akacha, PhD

Group Head of Statistical Methodology

Novartis Pharma AG, Switzerland

Aloka  Chakravarty, PhD

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)

Aloka  Chakravarty, PhD

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

Mark  Levenson, PhD

Panelist

Mark Levenson, PhD

FDA, United States

Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER

Gregory  Levin, PhD

Panelist

Gregory Levin, PhD

FDA, United States

Associate Director for Statistical Science and Policy, OB, OTS, CDER

John  Scott, PhD, MA

Panelist

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Frank  Bretz, PhD

Panelist

Frank Bretz, PhD

Novartis , Switzerland

Distinguished Quantitative Research Scientist

Andrew  Thomson, PhD, MA, MS

Panelist

Andrew Thomson, PhD, MA, MS

European Medicines Agency, Netherlands

Statistician, Methodology Taskforce

Greg  Ball, PhD

Panelist

Greg Ball, PhD

ASAPprocess, United States

Safety Data Scientist

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