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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V5-S4] What ICH E17 Would Bring to Global Drug Development

Session Chair(s)

Taro  Ishibashi, PhD, RPh

Taro Ishibashi, PhD, RPh


Pfizer R&D Japan, Japan

Now that ICH E17 passed Step 5, MRCTs utilizing the Guideline will be used for the global drug development from now on. The Guideline defines the fundamental rules in designing MRCTs for drug development, but it doesn’t define how the result of MRCTs should be analyzed and used for the judgment for drug approval. It will be the decision of each regulatory agency. In this session, we invite experts from various regions such as Japan, US, Europe or China, and ask them to discuss what changes this Guideline would bring to MRCTs, and what implications the Guideline would have for the submissions of new drugs. And then we will discuss what ICH E17 would bring to global drug development.


Joseph  Scheeren, PharmD

E17 Implication for Global Drug Development: US Perspective

Joseph Scheeren, PharmD

Scheeren HealthCare LLC, United States


Ling  Su, PhD

E17 Implication for Global Drug Development: China Perspective

Ling Su, PhD

Shenyang Pharmaceutical University, Yeehong Business School, China

Research Fellow

Norisuke  Kawai, PhD

E17 Implication for Global Drug Development: Statistical Consideration

Norisuke Kawai, PhD

Pfizer R&D Japan G.K., Japan

Senior Director, Head of Clinical Research

Ryuta  Nakamura, PhD

Ryuta Nakamura, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Review Director, Office of New Drug II