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Regulators Give Their Views on Clinical Data Management at Asian New Drug Development Conference

TOKYO, JAPAN — March 13, 2013

High-profile representatives from regulatory agencies across East Asia will give their country’s perspective on clinical data evaluation for drug approval at DIA Japan’s 7th Annual Conference for Asian New Drug Development in Tokyo, April 15-16.

During a session entitled “Perspectives of Respective Regulatory Agencies in Clinical Data Evaluation for Drug Approval,” Seong-ho Kim, director of pharmaceutical safety policy division at the Pharmaceutical Safety Bureau, Korea Food and Drug Administration (KFDA), will speak regarding the Republic of Korea’s perspective, and Li-Li Su, PK/PD reviewer for the division of pharmaceutical science at the Center for Drug Evaluation, will speak for Taiwan. The Chinese perspective will be given by DIA Board President, Dr. Ling Su, PhD, and Dr. Yoshiaki Uyama, PhD, director of regulatory science research division at Pharmaceuticals and Medical Devices Agency (PMDA), will speak for Japan.

The 7th Annual Conference for Asian New Drug Development will also feature a keynote speech from Joseph Cho, managing director of R&D-based Pharmaceutical Association Committee (RDPAC) in China, addressing the “Outlook for China Pharma R&D and Market: From RDPAC Viewpoint.”

The event, 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. The main theme for discussion will be how increasing multiregional clinical trial (MRCT) data should be utilized in New Drug Applications (NDA) in the region.

 

 

 

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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.