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Past Events
CASSS – Sharing Science Solutions
Cecilia Tami
Genentech, a Member of the Roche Group
Appearances
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ENGLISH - CASSS & CMC Strategy Forum Japan 2020 Welcome and Introductory Comments and Workshop Session One – Recent Trends in the Regulation of Biopharmaceutical Products
Date
December 7, 2020
Speakers
Wassim Nashabeh
F. Hoffmann-La Roche Ltd.
Robin Levis
Hiroyuki Arai
PMDA-Pharmaceuticals and Medical Devices Agency
Futaba Honda
PMDA-Pharmaceuticals and Medical Devices Agency
Ragini Shivji
European Medicines Agency (EMA
Marjorie Shapiro
CDER, FDA
Session Chairs
Shinichi Okudaira
PMDA-Pharmaceuticals and Medical Devices Agency
Cecilia Tami
Genentech, a Member of the Roche Group
Panelists
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
Date
December 7, 2020
Speakers
Robin Levis
Wassim Nashabeh
F. Hoffmann-La Roche Ltd.
Hiroyuki Arai
PMDA-Pharmaceuticals and Medical Devices Agency
Futaba Honda
PMDA-Pharmaceuticals and Medical Devices Agency
Ragini Shivji
European Medicines Agency (EMA
Marjorie Shapiro
CDER, FDA
Session Chairs
Shinichi Okudaira
PMDA-Pharmaceuticals and Medical Devices Agency
Cecilia Tami
Genentech, a Member of the Roche Group
Panelists
Yasuhiro Araki
PMDA-Pharmaceuticals and Medical Devices Agency
Fumihiko Takeshita
Daiichi Sankyo Co., Ltd.
Nuts and Bolts: A Perspective on the Impact of COVID-19 Pandemic Workshop Session Seven
Date
February 3, 2021
The COVID-19 pandemic has impacted the biopharmaceutical industry and regulatory agencies on many
Session Chairs
Cecilia Tami
Genentech, a Member of the Roche Group
Nomalie Jaya
Seagen Inc.
Roman Drews
Daiichi Sankyo Inc
Session Speakers
Zhihao (Peter) Qiu
CDER, FDA
Bénédicte Lebreton
Genentech, a Member of the Roche Group
Denise Papiernik
Bristol-Myers Squibb Company
James Jean
Pfizer, Inc.
ENGLISH - CASSS Introductory Comments, CMC Strategy Forum Japan Welcome and Recent Trends in the Regulation of Biopharmaceutical Products
Date
December 6, 2021
Speakers
Robin Levis
Nadine Ritter
Global Biotech Experts, LLC
Hiroyuki Arai
PMDA-Pharmaceuticals and Medical Devices Agency
Ryoko Naruse
PMDA-Pharmaceuticals and Medical Devices Agency
Cassandra Overking
CBER, FDA
Emily (Xianghong) Jing
CDER, FDA
Jason Turpin
Health Canada
Session Chairs
Cecilia Tami
Genentech, a Member of the Roche Group
Shinichi Okudaira
PMDA-Pharmaceuticals and Medical Devices Agency
Panel Member
Jun Matsumoto
PMDA-Pharmaceuticals and Medical Devices Agency
JAPANESE - CASSS Introductory Comments, CMC Strategy Forum Japan Welcome and Recent Trends in the Regulation of Biopharmaceutical Products
Date
December 6, 2021
Speakers
Nadine Ritter
Global Biotech Experts, LLC
Robin Levis
Hiroyuki Arai
PMDA-Pharmaceuticals and Medical Devices Agency
Ryoko Naruse
PMDA-Pharmaceuticals and Medical Devices Agency
Cassandra Overking
CBER, FDA
Emily (Xianghong) Jing
CDER, FDA
Jason Turpin
Health Canada
Session Chairs
Cecilia Tami
Genentech, a Member of the Roche Group
Shinichi Okudaira
PMDA-Pharmaceuticals and Medical Devices Agency
Panel Member
Jun Matsumoto
PMDA-Pharmaceuticals and Medical Devices Agency