Oct. 13 (Thu.) ,2016 15:00-16:00

Annex Hall
F204

Simultaneous Interpretation

Korea National Enterprise for Clinical Trials (KoNECT)

Special Lecture for Japan-Korea's Clinical Trials: Fostering Successful Asia MRCT through Japan-Korea Collaboration

The holy grail of pharmaceutical industry is to bring innovative medicine to patients in the most efficient and timely manner. In achieving this goal, MRCT (Multi-Regional Clinical Trials) has rapidly been adopted as the most effective strategy, and the health agencies have been taken multiple initiatives in paving relevant regulatory pathways. In Asia, MRCT approaches attracted even more attentions, due to ethnic similarity and commonly unmet medical needs in the region. Particularly in Japan, out of >100 medicinal products approved by PMDA since the establishment of MRCT guideline, approximately 30% were through Asia MRCT. The purpose of this session is to provide informative insights on MRCT acceleration strategy through collaboration with Korea, one of the most preferred destination to global clinical trial sponsors. Experts from academy, industry, and government will be providing scientific evidence and cases, together with introduction of Korean government’s supporting program.

Cordinator

Kelly Han

Manager, Business Development and Global Cooperation, KoNECT

Absence of Significant Difference in the pharmacokinetics among East Asian Ethnic Groups

In-Jin Jang

Professor, Seoul National University Hospital

Why East Asia Collaboration is Important in MRCT and Strength of Korea Clinical Trial

Miyazaki Koichi

Senior Director, Daiich-Sankyo

How KoNECT facilitates Japan-Korea Collaboration

Deborah Chee

President, KoNECT

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