返回 Agenda
Session Chair(s)
Yoshihiko Ono, RPH
Regulatory Executive Advisor
MSD K.K., Japan
Speaker(s)
Should the key Action Date be set in the J-NDA review process ? - Comparison to EMA/CP.
Hirotaka Chaki
Bayer Yakuhin, Ltd., Japan
Head of Regulatory Information Management; Product Development
Should the key Action Date be set in the J-NDA review process? - The merit and demerit
Hiroyuki Sato, MS
Shionogi & Co., Ltd., Japan
Deputy General Manager, Product Development Regulatory Affairs Dept
Current situation of J-NDA review process and management
Shinobu Uzu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director