ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN

Track:
Globalisation

Day & Time:
March 6, 2:00PM - 3:30PM

Session Number:
1307

Room Number:
E102

Level:
Intermediate

Type:
Session

Title:
ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN

Chair(s):
Nobumasa Nakashima
Director, Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Description:
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(s):
(1) To understand how leading international regulatory harmonization initiatives are functioning (2) To discuss future directions of harmonization activities

Presentation(s) & Speaker(s):
International Cooperation and Consideration on Multi-Regional Clinical Trial among Asia
Shinobu Uzu
Office Director, Office of New Drug I
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Asia – the world’s fastest growing market: perspective from the pharmaceutical industry
Ira Wolf, MA
Japan Representative
PhRMA, Japan

Challenges to Asian Companies to Comply with European Legislation on (Traditional) Herbal Medicinal Products
Werner Knoess, DrSc
Head of Department/BfArM and Chair of the HMPC/EMA
BfArM, Germany