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Session 4: Lessons Learned from Actual Experiences - Case Example of Drug Approval in Asia through Global Development -
Session Chair(s)
Ari Fujishiro
Senior Director, Regulatory Affairs Group, Asia Development Dept., R&D Division
Daiichi Sankyo Co., Ltd., Japan
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)
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
Experiences of Ruxolitinib Pan-Asian Registration Study
Hideyasu Ishibashi, PhD
Novartis Pharma K.K., Japan
Head, Translational Clinical Oncology
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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