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Practical Implementation of MRCTs Based on ICH E17 Guidelines
Session Chair(s)
Yoshiaki Uyama, PhD, MS, RPh
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning a study or evaluating results.
Learning Objective : Explain how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.
Speaker(s)
Panelist
Armin Koch, DrSc
Hannover Medical School, Germany
Head, Institute of Biometry
Panelist
Adriane Alves de Oliveira, MSc
ANVISA, Brazil
Health Regulation Expert
Panelist
Hideki Hiraoka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug ?
Panelist
William Wang, PhD
Merck & Co, Inc, United States
Executive Director
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