James Cai | VP, Global Regulatory Affairs for JAPAC
Amgen | China

James Cai, VP, Global Regulatory Affairs for JAPAC, Amgen

James Cai joined Amgen as Vice President of Regulatory Affairs, Japan Asia Pacific (JAPAC) since May 2014. His focus is to lead and oversee development and implementation of regulatory strategies across multiple countries, which currently includes Australia, China, Japan, India, Malaysia, Singapore, South Korea, Taiwan and Thailand.
 
Prior to Amgen, Dr. Cai worked for Roche / Genentech as head of Asia Early Phase Clinical Development strategy, Vice President of Medical Affairs Roche China. He worked with AstraZeneca as R&D head China, and with other MNCs including Pfizer and MSD as Medical Director and External Affairs Director respectively.  

Dr. Cai is trained as Medical Physician, Clincial Researcher from Shanghai Jiao Tao University Medical School, New York University Medical School, EMBA from Columbia University.

Appearances:



Phar-East Day Two @ 11:10

Multi regional clinical trial (MRCT) harmonisation: An overview

This one hour session includes an overview presentation on MRCT in Asia, with quick 10-minute updates from Japan, Taiwan, Malaysia, Singapore and a combined 20 minutes panel session to discuss regulatory challenges from both regulator and pharma perspectives, successes so far and what can be expected in the year of 2020
 
11:20 Overview of MRCT in Asia
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
 
11:30 ICH E17
Koichi Miyazaki, Senior Director, Regulatory Affairs, Asia Development Department, Daiichi Sankyo, Japan
 
11:40 Japan
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
11:50 Taiwan
I-Ning Tang, Senior Reviewer, Centre For Drug Evaluation, Taiwan
 
12:00 China
Gloria Wang, Executive Director, Clinical Development Just Biotherapeutics, China
 
12:10-12:40 Panel: Successes and future strategies to promote cross-country drug development
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
I- Ning Tang, Senior Reviewer, Centre For Drug Evaluation, Taiwan
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
Gloria Wang, Executive Director, Clinical Development, Just Biotherapeutics, China
Koichi Miyazaki, Senior Director, Regulatory Affairs, Asia Development Department, Daiichi Sankyo, Japan

back to speakers