10th Annual Meeting DIA Japan 2013

In a current clinical drug development strategy, efforts of simultaneous regulatory submission have been making to obtain registration and approval in Europe, the United States, and Japan. Multinational/ regional clinical trials have been the key practice in order to obtain simultaneous approvals in different regions. These trials include several geographic regions where ethic factors may differ and, as a result, the response to a drug may vary according to the different interethnic differences, racial background, and environmental and cultural factors, including the regional medical practice. Under such an environment, pharmaceutical companies have been trying and struggling with different courses of drug development strategy and operational model strategy to find a better, faster, and easier strategy with a specific drug and a specific indication in different regional and environmental settings. In this session, different development strategy approach and a new operational excellent initiative that global pharmaceutical companies have been pursuing will be discussed. The audience will be shared with the newest global/multiregional approach to a simultaneous regional drug development strategy including Japan and Asian countries.