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[V2-S4] For the Success of the Global/Asia MRCT
Session Chair(s)
Eri Sekine
Executive Vice President Data Business, CMIC Co., Ltd, Japan
Globalization of drug development progresses, and cases in which Japan leads clinical trials in the Asia region, and/or participates upon request in multi-regional clinical trials (MRCTs) from early stage of clinical development, are increasing. On the other hand, we have often seen confusion in globalization or MRCTs due to not only language barriers, but also different cultures, medical environments, and regulations between Japan and other regions. To demonstrate Japanese leadership globally, we must build up more experience in these areas. Presenters experienced in MRCTs from the global and Asian perspectives, from various pharmaceutical companies, will introduce the challenges and efforts of successful MRCTs, and how Japan can demonstrate the knowledge, the skills, and mindset necessary to lead global drug development.
Speaker(s)
Kazutaka Suga, PHD
Senior Manager, Japan/Asia Clinical Development 1, Development, Astellas Pharma Inc., Japan
To Maximize Japan/Asia Presence in P3 MRCT
Nobuhiro Koga, MBA, PMP
Director, ICTR-Japan, Nihon Servier Co., Ltd., Japan
Rebuild of Strategic Collaboration with Global CRO for Successful MRCT
Fuminori Shindoh
Group Manager, Translational Clinical Research Division, Chugai Pharmaceutical Co., Ltd., Japan
Expectation and Role of Japan in Global Drug Development Based on Experience of MRCT for Last 10 Years
Hideyasu Ishibashi, PHD
Head, Translational Clinical Oncology, Novartis Pharma K.K., Japan
Joining Global First-in-Human Studies in Oncology Drug Development
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