Pharmaceutical Quality Forum: 3rd Symposium


Title: Future Pharmaceutical Quality System by Product Understanding and Risk Management

Date: 11/22/04
Location: Tokyo, Japan
E-mail: hinshitsu@nihs.go.jp
Telephone: +88-3-3700-1141
Fax: +88-3-3707-6950
　　　　　　　　　　　　　　　　　　　　　　　　　

Welcome Remarks MHLW

Chair Emer Cooke (EU), Shigeo Kojima (Pharmaceutical Quality Forum)
9:00-9:40John Berridge ( EFPIA)Pharmaceutical Development in Quality System
9:40-10:20Ajaz Hussain (US FDA) Effective Regulatory system through Process Understanding
10:20-10:50 Haruhiro Okuda(MHLW) Revised Pharmaceutical Affair Law and Pharmaceutical Development
10:50-11:20 Akira Kato　 (JPMA) Japanese Industry's Perspectives
11:20-11:40 Panel Discussion

Lunch Break


Chair David Horowitz (US FDA) and Yoshio Kitazawa (JPMA)

13:00-13:40 Peter Gough (EFPIA) Quality Risk Management
13:40-14:20 Emer Cooke (EU) Risk Based Regulations and Challenges
14:20-14:50 Yukio Hiyama (MHLW) Quality Regulation under Revised Pharmaceutical Affair Law

14:50-15:10 Break

15:10-15:40 Takayoshi Matsumura (JPMA)
15:40-16:10 Tetsu Yamada (JPMA)Quality Systems for the Future
16:10-16:55 PANEL Discussion

Closing Remarks JPMA



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