ENGLISH - CASSS & CMC Strategy Forum Japan 2020 Welcome and Introductory Comments and Workshop Session One – Recent Trends in the Regulation of Biopharmaceutical Products

Speaker(s):

• Robin Levis

Speaker(s):

• Wassim Nashabeh, F. Hoffmann-La Roche Ltd.
• Hiroyuki Arai, PMDA-Pharmaceuticals and Medical Devices Agency

Session Chair(s):

• Shinichi Okudaira, PMDA-Pharmaceuticals and Medical Devices Agency
• Cecilia Tami, Genentech, a Member of the Roche Group

Speaker(s):

• Futaba Honda, PMDA-Pharmaceuticals and Medical Devices Agency
• Ragini Shivji, European Medicines Agency (EMA
• Marjorie Shapiro, CDER, FDA

Panelist(s):

• Yasuhiro Araki, PMDA-Pharmaceuticals and Medical Devices Agency
• Fumihiko Takeshita, Daiichi Sankyo Co., Ltd.