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[V5-S4] What ICH E17 Would Bring to Global Drug Development
Session Chair(s)
Taro Ishibashi, PhD, RPh
President
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.
Speaker(s)
E17 Implication for Global Drug Development: US Perspective
Joseph Scheeren, PharmD
Scheeren HealthCare LLC, United States
Founder
E17 Implication for Global Drug Development: China Perspective
Ling Su, PhD
Shenyang Pharmaceutical University, Yeehong Business School, China
Research Fellow
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
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of New Drug II
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