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[Session 1] Announcement of ICH S7B
Session Chair(s)
Satoshi Tsunoda
Specialist, Office of New Drug IV
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Takashi Yoshinaga
Executive Director, Advanced Biosignal Safety Assessment
Eisai Co., Ltd., Japan
Speaker(s)
ICH S7B Q&A Points to Consider (Step 2) In Vitro Best Practice
Gary Gintant, PHD
AbbVie Inc., United States
Research Fellow
ICH S7B Q&A Point to consider, In vivo best practice
Katsuyoshi Chiba, PHD
Daiichi Sankyo Co., Ltd., Japan
Senior Director and Head, Group III, Medicinal Safety Research Laboratories, R&D
ICH S7B Q&A: Points to consider for S7B Integrated Risk Assessment
Zhihua Li, PHD
Food and Drug Administration, United States
Biologist, Div. of Applied Regulatory Science, Office of Clinical Pharmacology,