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Virtual

Jan 29, 2021 10:00 AM - Jan 29, 2021 6:30 PM

8th DIA Cardiac Safety Workshop in Japan

[Session 1] Announcement of ICH S7B

Session Chair(s)

Satoshi  Tsunoda

Satoshi Tsunoda

Specialist, Office of New Drug IV

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Takashi  Yoshinaga

Takashi Yoshinaga

Executive Director, Advanced Biosignal Safety Assessment

Eisai Co., Ltd., Japan

Speaker(s)

Gary  Gintant, PhD

ICH S7B Q&A Points to Consider (Step 2) In Vitro Best Practice

Gary Gintant, PhD

AbbVie Inc., United States

Research Fellow

Katsuyoshi  Chiba, PhD

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

Zhihua   Li, PhD

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,

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