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

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

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
 
11:00 Overview of MRCT in Asia
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
 
11:10 Japan’s latest MRCT ICH guidelines
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
11:20 Taiwan
I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
11:30 China
Gloria Wang, Executive Director, Clinical Development Just Biotherapeutics, China
 
11:40 Singapore
 
11:50 Panel: What successes have we achieved so far and how can we build a better synergy model to promote cross-country drug development?
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China

I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
Gloria Wang, Executive Director, Clinical Development, Just Biotherapeutics, China

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