Vol.37, Suppl XXVII Aug. 2009　Learning from Experience and New Challenges for the Future

Contents
Preface	Takeuchi M, Lagakos SW	iii
Faculty Members		iv
Program		xvi
●Opening
Opening Remarks	Inoue M	3-4
Congratulatory Remarks	Nakagaki T	5-7
Welcoming Address	Ryan LM	9
●Session 1
How to share the knowledge on NDA review across nations/regions	Chairperson : Imura H	11
FDA's present situation and future prospects	Justice RL	13-8
Japan's Activities	Akagawa H	19-26
Future Prospects of Asian Region 　　　Global Drug Development in China - What we can do?	Chen X	27-32
Future Prospects of Asian Region “Partnership in Harmonization” with 　　　a Proposal of “APEC Pharmaceutical Evaluation Report (PER) Scheme” 　　　from Taiwan	Chern HD	33-8
Panel Discussion		39-51
●Session 2
Consideration for promoting global drug development	Chairperson : Ikeda Y	53
Consideration for Promoting Global Drug Development 　　　Based on the Collaboration of Academia with Industry	Takeuchi M	55-63
How to promote global clinical trial in Asia Pacific region? Korean Perspectives	Lee D	65-71
Learning from Experience and New Challenges for the Future	Sawada T	73-8
Clinical Trial Environment in Japan Expectations of sponsors to medical institutions	Gómez JC	79-89
Panel Discussion		91-8
●Key Note	Chairperson : Takeuchi M	99
Problems of Medical Practice in Japan	Kanazawa I	101-16
●Session 3
New challenges for the development of medical technology / medicine in Japan	Chairperson : Ryan LM	117
Consideration in Stage-Specific Treatment Approach in Progressive Diseases	Makino H	119-32
Drug Evaluation by Surrogate Marker	Uyama Y	133-41
Effectiveness of Prophylactic Vaccine	Shikano M	143-50
Leveraging Prior Knowledge in Guiding Drug Development and Regulatory 　　　Decisions	Jadhav PR	151-9
Panel Discussion		161-9
●PhRMA Luncheon seminar	Chairperson : Kobayashi T	171
Action plan for the solution:Infrastructure for clinical trials 　　　and Drug lag for approval	Hatake K	173-201
●Session 4
For the enhancement of new drug development in Japan	Chairperson : Aizawa Y	203
For the Development of Human Resources	Araki K	205-14
Reinforcement of research and development infrastructure	Chimura H	215-28
Issues around the Promotion of Pharmaceutical Development in Japan	Kurata K	229-43
●Session 5
Consistent Safety Risk Management Through the Producut Life Cycle 　　　from Clinical Developemnt to Post Approval	Chairperson : Takeuchi M	245
For the Earlier Signal Detection	Narukawa M	247-54
Efforts of Regulatory Authority in Japan	Misawa K	255-61
Safety Risk Management Company Perspective	Harada A	263-9
Panel Discussion		271-81
●Session 6
Physician Growing Program - Human Resources Development 　　　for Global Clinical Trials	Chairperson :Satoh T	283
Further Education for physicians/investigators to boost Global Trials: 　　　Issues and challenges the core sites face	Sato Y	285-9
Human resources for global clinical trials in Japan: 　　　Lags, lacks, and suggestions for improvement	Bax L	291-8
Global Clinical Trials of Medical Devices - Complementary Approach with 　　　Global Harmonization Task Force (GHTF) and Harmonization by Doing (HBD) -	Sase K	299-310
●Conclusion & Closing Remarks
Conclusion	Ryan LM	313
Closing Remarks	Takeuchi M	315-6

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