ENGLISH - CASSS & CMC Strategy Forum Japan 2020 Welcome and Introductory Comments and Workshop Session One – Recent Trends in the Regulation of Biopharmaceutical Products
Dec 7, 2020 9:00am ‐ Dec 7, 2020 12:50pm
Speaker(s):
- Wassim Nashabeh, F. Hoffmann-La Roche Ltd.
Speaker(s):
Speaker(s):
- 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.
JAPANESE - CASSS & CMC Strategy Forum Japan 2020 Welcome and Introductory Comments and Workshop Session One – Recent Trends in the Regulation of Biopharmaceutical Products
Dec 7, 2020 9:00am ‐ Dec 7, 2020 12:50pm
Speaker(s):
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.
ENGLISH - Workshop Session Two - Implementation of ICH Q12 – Where Are We in Japan and Globally?
Dec 8, 2020 9:00am ‐ Dec 8, 2020 12:00pm
Session Chair(s):
- Akiko Ishii-Watabe, NIHS-National Institute of Health Sciences
- Markus Goese, F. Hoffmann-La Roche Ltd.
Speaker(s):
- Joel Welch, CDER, FDA
- Yoshinori Kubodera, Chugai Pharmaceutical Co., Ltd.
- Keiko Funato, GlaxoSmithKline K.K
- Satomi Yagi, PMDA-Pharmaceuticals and Medical Devices Agency
Panelist(s):
Speaker(s):
- Wassim Nashabeh, F. Hoffmann-La Roche Ltd.
JAPANESE - Workshop Session Two - Implementation of ICH Q12 – Where Are We in Japan and Globally?
Dec 8, 2020 9:00am ‐ Dec 8, 2020 12:00pm
Session Chair(s):
- Markus Goese, F. Hoffmann-La Roche Ltd.
- Akiko Ishii-Watabe, NIHS-National Institute of Health Sciences
Speaker(s):
- Joel Welch, CDER, FDA
- Yoshinori Kubodera, Chugai Pharmaceutical Co., Ltd.
- Keiko Funato, GlaxoSmithKline K.K
- Satomi Yagi, PMDA-Pharmaceuticals and Medical Devices Agency
Panelist(s):
Speaker(s):
- Wassim Nashabeh, F. Hoffmann-La Roche Ltd.