Koichi Miyazaki | Senior Director, Regulatory Affairs Group
Daiichi Sankyo, Inc | Japan

Koichi Miyazaki, Senior Director, Regulatory Affairs Group, Daiichi Sankyo, Inc

Koichi Miyazaki is currently Asia region head of regulatory affairs.  In this capacity, he is responsible for wide range of regulatory affairs issues including IND, NDA, and post-NDA approval requirements in Asia excluding Japan. 

Prior to taking current position, he was project leader responsible for Asian countries in mega-global studies and his responsibilities include developing, implementing, and maintaining a global operational strategy that supports all clinical trial activities, and also management of subsidiary offices in Asia.

Before taking project leader position, he spent years in US as project manager with overall responsibilities for study operational aspects of clinical trials both in US local studies and global studies in cardiovascular field.  He also served as liaison between East and West to harmonize differences in culture and practice to establish standardized procedures applicable for all studies.  His areas of interest include cross-cultural communication and optimization of broad range of differences among regions.

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 ICH E17
Koichi Miyazaki, Senior Director, Regulatory Affairs, Asia Development Department, Daiichi Sankyo, Japan
 
11:20 Japan
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
11:30 Taiwan
I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
11:40 China
Gloria Wang, Executive Director, Clinical Development Just Biotherapeutics, China
 
11:50-12:30 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 Senior Reviewer, Center 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

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