7th Annual Conference in Japan for Asian New Drug Development

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Workshop 2: Exploring Best Practices on Clinical Development related to Multi Regional Clinical Trials (MRCTs) in China, Korea, and Taiwan (2nd)

Session Chair(s)

Yuko Kikuchi, MS, RPh

Senior Director, Asia Regulatory Affairs

Eisai Co., Ltd., Japan

Tetsuomi Takano, RPh

Editor-in-Chief

Drug R&D Expert, Japan

The interactive tutorial sessions on new drug development in China, Korea, and Taiwan, which were very well received in last year’s conference (cf. Therapeutic Innovation & Regulatory Science 47 (1) 133-139, 2013), are again scheduled as “workshop” for the afternoon of Day 2 of this 7th Annual Conference. Panelists who have day-to-day experience in new drug development in Asia will lead the workshop, which will be particularly helpful to those who are planning to fi le IND/NDA in the region, who are interested in regulations and clinical development operations in East Asia, or who are already working on the front line of clinical development. The panelists will share their best practical know-how and tips on development regulatory affairs (at Workshop Session 1) and clinical development (at Workshop Session 2) related to MRCTs in China, Korea, and Taiwan from viewpoints of Japanese pharmaceutical companies and contract research organizations (CROs). Examples of China CDE panel meetings, consultations with regulatory agencies, updated regulatory information related to clinical trial (e.g. requirements for NDA submissions), along with some other topics, will be covered in Session 1. Selections of CROs and vendors, considerations on local IND holders, points to consider in conducting MRCTs in China, Korea, and Taiwan, audit findings to clinical study sites, exportation of blood samples from the region, and other topics will be covered in Session 2. Participants will have ample time for Questions and Answers and will be able to obtain valuable information. Please join us at this insightful workshop.

Speaker(s)

Judy Kai, MLS, RN

ICON Japan K.K., Japan

Global Account Director

Min Kim

EPS International (Korea) Limited, Korea, Republic of

Country Director

Satoshi Kokubo, DVM, PhD

Astellas Pharma Inc., Japan

Senior Director, Medical Affairs

Kosuke Mitsui, MBA, MSc, PMP

Chugai Pharma Science (Beijing) Co., Ltd., China

President & General Manager

Kensuke Morimoto, MSc

Daiichi Sankyo Company, Limited, Japan

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