Overview
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PURPOSE
• With the ICH reform, the new ICH organization will reinforce the foundations of ICH to make it better equipped to face the of global pharmaceutical development and regulation.
• The future ICH activities have almost the same direction with those of DIA, which has served as a global forum with increasing its global reach.
• It will be a great opportunity to have a joint workshop with collaboration between ICH and DIA in good timing when the ICH Osaka Meeting (Nov5-10, 2016) and DIA Japan Annual Meeting (Nov 13-15, 2016), in order to share major outcomes from the ICH Osaka Meeting as well as to discuss its implications.
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Program Committee
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Tatsuo Kurokawa, DIAFellow, PhD Director General
The Japan Biosimilar Association, Japan -
Junko Sato, PhD Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Hironobu Saito, PhD Specially Appointed Professor
Tottori University, Chromosome Egineering Research Center, Japan -
Yoshihiro Katsura, MS Regulatory Coordination Officer
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Michelle Limoli, PharmD, RPh Senior International Health Science Advisor, Office of the Director, CBER
FDA, United States -
Masafumi Yokota, DVM, PhD Senior Director
Daiichi Sankyo Co., Ltd., Japan -
Emi Tomotake Regulatory Affairs
Otsuka Pharmaceutical Co., Ltd., Japan -
Yoshiaki Uyama, PhD, RPh Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Satoshi Saeki, MSc Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan -
Rie Matsui, RPh Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan -
Joan Wilmarth Blair, MA Senior Advisor for International Affairs to the Director/Deputy Director, CBER
FDA, United States -
Sabine Luik EFPIA Member ICH Steering Committee, Sr Vice President Medicine & Regulatory
Boehringer Ingelheim Pharmaceuticals, United States
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