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TOC Ariake Convention Hall

Apr 13, 2016 9:00 AM - Apr 14, 2016 6:00 PM

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

Experience of International Trial across Asia in Aripiprazole IM Depot

Naoaki Shimizu

Otsuka Pharmaceutical Co., Ltd., Japan

Group Leader, HQ of Clinical Development Dept of Clinical Management, CNS Gr 3

Hideyasu  Ishibashi, PhD

Experiences of Ruxolitinib Pan-Asian Registration Study

Hideyasu Ishibashi, PhD

Novartis Pharma K.K., Japan

Head, Translational Clinical Oncology

George (Chih-Heng)  Yeh, MBA

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

George (Chih-Heng) Yeh, MBA

Taiwan Liposome Company, Ltd., Taiwan

President

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