メニュー 戻る[Session 1] Announcement of ICH S7B

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

  • Research Fellow
  • AbbVie Inc., United States
Katsuyoshi  Chiba, PhD

ICH S7B Q&A Point to consider, In vivo best practice

Katsuyoshi Chiba, PhD

  • Senior Director and Head, Group III, Medicinal Safety Research Laboratories, R&D
  • Daiichi Sankyo Co., Ltd., Japan
Zhihua   Li, PhD

ICH S7B Q&A: Points to consider for S7B Integrated Risk Assessment

Zhihua Li, PhD

  • Biologist, Div. of Applied Regulatory Science, Office of Clinical Pharmacology,
  • Food and Drug Administration, United States

お問い合わせ

Please contact DIA Japan for further information.

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