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Bethesda North Marriott Hotel and Conference Center

24 abr 2018 7:00 a.m. - 25 abr 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling Conference

Session 4: Japan and Asia Updates

Session Chair(s)

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, International Labeling

Pfizer R&D Japan G.K., Japan

Japanese labels must be updated according to the new regulations, and necessary preparations for the potential impact of the new regulation on global labeling will be discussed. This session will also provide PMDA initiatives in Asia and updates on important labeling-related regulatory trends in Asia, including China, Singapore, Korea, and Vietnam.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the new labeling regulations for Japan and how to prepare for the revision
  • Discuss the impact of the new labeling regulations for Japan on global labeling
  • Discuss PMDA initiatives and regulatory trends related to labeling in Asia

Speaker(s)

Shinobu  Uzu, PhD

New Labeling Regulations in Japan and PMDA Initiatives in Asia

Shinobu Uzu, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Senior Executive Director

Rie  Matsui, RPh

Labeling in Asia: A Dynamic Landscape

Rie Matsui, RPh

Pfizer R&D Japan G.K., Japan

Senior Director, Regional Labeling Head for APAC, International Labeling

Panel  Discussion

Panel Discussion

All Session Speakers, United States

Panel  Q&A

Panel Q&A

United States

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