Menu Back toSession-9-ICH-Guidances-from-a-Global-and-Regional-Perspective

DIA/FDA Biostatistics Industry and Regulator Forum

Session 9: ICH Guidances from a Global and Regional Perspective

    Session Chair(s)
      Aloka  Chakravarty, PhD

      Aloka Chakravarty, PhD

      • Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER
      • FDA, United States
      William  Wang, PhD

      William Wang, PhD

      • Executive Director, Clinical Safety Statistics, BARDS
      • Merck Research Laboratories, United States

    This session will examine a few ICH regulatory guidances, looking at them both from global and regional perspectives. These guidances may include the recently published ICH E9 R1 step 2b draft, the soon-to-be-published ICH E17, and the upcoming ICH E6/E8 renovation.

    In this session, we will prepare a case-study scenario for the panelists, then we will let panelists develop their own estimands in advance, which they have to present briefly and subsequently defend during the panel discussion. We will further introduce additional complexities by different intrinsic/extrinsic factors and critical quality factors across region. This will lead to the discussion of E9 R1, E17, and E6/E8 in an implementation setting.

    The panel discussion will be mixed with short presentations on the relevant ICH guidance and its regional implementation.

    Learning Objective : At the conclusion of this session, participants should be able to:
    • Achieve a better understanding of the current status of key ICH guidance: E9 R1, E17, E6/E8 renovation
    • Discuss the landscape of regulatory statistics in various regions
    • Use the real case-study to illustrate the estimand concept and its MRCT implications
      Mouna  Akacha, PhD


      Mouna Akacha, PhD

      • Statistical Methodologist
      • Novartis Pharma AG, Switzerland
      Thomas J. Permutt, PhD

      Thomas J. Permutt, PhD

      • Assoc. Dir. for Statistical Science & Policy, Office of Biostatistics, OTS, CDER
      • FDA, United States
      Toshimitsu  Hamasaki, PhD, MS

      Some Observations on Regulatory Statistics Landscape in Japan

      Toshimitsu Hamasaki, PhD, MS

      • Director of Data Science
      • National Cerebral and Cardiovascular Center, Japan
      Devan V. Mehrotra, PhD


      Devan V. Mehrotra, PhD

      • Senior Director, Biostatistics Department
      • Merck Research Laboratories, United States
      Xiang  GUO, PhD

      An Overview of Regulatory Statistics in China

      Xiang GUO, PhD

      • Executive Director, Biometrics
      • Beigene, China