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ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN
Session Chair(s)
Nobumasa Nakashima
Health Policy Director, National Healthcare Policy Secretariat
Cabinet Office, Japan
Asia is gaining in importance in drug development, production, and marketing. This session discusses the efforts by the regulatory authorities and industry from Japan, US and EU to promote drug development in Asia and global cooperation at the international community.
Learning Objective : (1) To understand how leading international regulatory harmonization initiatives are functioning (2) To discuss future directions of harmonization activities
Speaker(s)
International Cooperation and Consideration on Multi-Regional Clinical Trial among Asia
Shinobu Uzu, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director
Asia – the world’s fastest growing market: perspective from the pharmaceutical industry
Ira Wolf, MA
Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Japan Representative
Challenges to Asian Companies to Comply with European Legislation on (Traditional) Herbal Medicinal Products
Werner Knoess, DrSc
BfArM, Germany
Head of Department/BfArM and Chair of the HMPC/EMA
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