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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)
Gary Gintant, PHD
Research Fellow, AbbVie Inc., United States
ICH S7B Q&A Points to Consider (Step 2) In Vitro Best Practice
Katsuyoshi Chiba, PHD
Senior Director and Head, Group III, Medicinal Safety Research Laboratories, R&D, Daiichi Sankyo Co., Ltd., Japan
ICH S7B Q&A Point to consider, In vivo best practice
Zhihua Li, PHD
Biologist, Div. of Applied Regulatory Science, Office of Clinical Pharmacology, , Food and Drug Administration, United States
ICH S7B Q&A: Points to consider for S7B Integrated Risk Assessment
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