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TOC Ariake Convention Hall

2016 年 04 月 13 日 9:00 上午 - 2016 年 04 月 14 日 6:00 下午

3-5-7 Ariake, , Koto-ku, Tokyo, 135-0063 Japan

10th DIA Asia New Drug Conference in Japan

The registrants will have access to presentation PDFs through Thursday, October 13, 2016.

Session 4: Lessons Learned from Actual Experiences - Case Example of Drug Approval in Asia through Global Development -

Session Chair(s)

Ari  Fujishiro

Ari Fujishiro

Senior Director, Regulatory Affairs Group, Asia Development Dept., R&D Division, Daiichi Sankyo Co., Ltd., Japan

Jessica (Chih Min)  Lin, MBA, MSC

Jessica (Chih Min) Lin, MBA, MSC

General Manager of Development Division, Chugai Pharma Taiwan Ltd., Taiwan

With concern to accelerated progression of Asia new drug development, the global clinical development strategy has become important and be aware by all pharma industry. Each company elaborates the clinical development plan of new compound to confirm safety, efficacy, and benefit for patients as well as to accelerate the process that the new drug can bring into market to benefit patients as early as possible with best practice. Such well-established strategies and plans would contribute to expedite the approval processes of new products. We do hope our audiences can learn from this session and understand how a meticulous clinical development plan and regulatory submission strategies for a new drug in Asia and/or global level can shorten the review process and minimize the risk from industry’s point of view and their experiences. To achieve the deliverables of getting approval, comprehensive discussion in each company might be made. Through the session, the audiences will be able to learn various key factors needed to be considered at clinical development stage and review phase.

Speaker(s)

Naoaki  Shimizu

Naoaki Shimizu

Group Leader, HQ of Clinical Development Dept of Clinical Management, CNS Gr 3, Otsuka Pharmaceutical Co., Ltd., Japan

Experience of International Trial across Asia in Aripiprazole IM Depot

Hideyasu  Ishibashi, PHD

Hideyasu Ishibashi, PHD

Head, Translational Clinical Oncology, Novartis Pharma K.K., Japan

Experiences of Ruxolitinib Pan-Asian Registration Study

George (Chih-Heng)  Yeh, MBA

George (Chih-Heng) Yeh, MBA

President, Taiwan Liposome Company, Ltd., Taiwan

Bridging East and West – Oncology NCE TLC388 to Fill the Gap

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