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Experts to Discuss a “Key Strategic Option” in New Drug Development

TOKYO, JAPAN — Mar 4, 2013

Professionals in new drug development and regulatory agencies will discuss the challenges and benefits of using multiregional clinical trial (MRCT) data at the DIA 7th Annual Conference for Asian New Drug Development in Japan, April 15-16.

The conference, to be held at Nakano Sunplaza in Tokyo, will provide a forum for exchange of opinions among pharmaceutical industry professionals, academia, and the regulatory agencies in East Asia, including the Pharmaceuticals and Medical Devices Agency (PMDA), about how increasing MRCT data should be utilized in New Drug Applications (NDA) in the region.

Program Chair Dr. Kihito Takahashi, MD, PhD, vice president Japan development and medical affairs division, GlaxoSmithKline K.K., said: “MRCTs in East Asia, including Japan, China, Korea, and Taiwan, are now considered one of the promising key strategic options in new drug development. The Ministry of Health, Labour and Welfare (MHLW) stressed the importance of smooth and appropriate conduct of MRCTs in East Asia in “Basic Principles on Global Clinical Trials (Reference Cases)”, published in September 2012.

“As understanding has deepened through experience with these trials, it is an urgent imperative for industry, government, and academia to come together to discuss and resolve outstanding issues, and make improvements in collaboration internationally to activate new drug development in Asia.”

The 7th Annual Conference for Asian New Drug Development will feature keynote presentations by high-profile speakers from the pharmaceutical industry in China and Japan, addressing proposed strategies of development in the region. Well-recognized experts in new drug development and reviewers in regulatory agencies from Japan, China, Korea, Taiwan and other countries will attend as speakers and panelists to take part in active discussion aiming to enhance new drug development.

For more information about the event, or to register, visit www.diahome.org/AsiaNewDrugDev.






ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.