Volver a Agenda
[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
Founder, Scheeren HealthCare LLC, United States
E17 Implication for Global Drug Development: China Perspective
Research Fellow, Yeehong Business School, China
E17 Implication for Global Drug Development: Statistical Consideration
Senior Director, Head of Clinical Research, Pfizer R&D Japan G.K., Japan
Ryuta Nakamura, PHD
Review Director, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
¿Tiene una cuenta?