ENGLISH - CASSS Introductory Comments, CMC Strategy Forum Japan Welcome and Recent Trends in the Regulation of Biopharmaceutical Products

Speaker(s):

• Robin Levis

Speaker(s):

• Nadine Ritter, Global Biotech Experts, LLC
• Hiroyuki Arai, PMDA-Pharmaceuticals and Medical Devices Agency

Session Chair(s):

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

Speaker(s):

• Ryoko Naruse, PMDA-Pharmaceuticals and Medical Devices Agency
• Cassandra Overking, CBER, FDA
• Emily (Xianghong) Jing, CDER, FDA
• Jason Turpin, Health Canada

Panel Member(s):

• Jun Matsumoto, PMDA-Pharmaceuticals and Medical Devices Agency