| Preface | Takeuchi M Lagakos SW | iii |
| Faculty Members | iv-xix | |
| Program | xx-xxiii | |
| Opening Remarks and Welcoming Address | Inoue M | 1-2 |
| Congratulatory Remarks | Kishida S | 3-4 |
| Welcoming Address | Doogan DP | 5-6 |
| SESSION 1: GLOBAL PROGRAM: IS THERE A REALITY? | Chairperson: Doogan DP | 7-52 |
| Lessons Learned from Three Global(Mega-) Clinical Trials | Takeuchi M | 9-16 |
| Clinical Perspective; Template on Global Clinical Study Protocols | Kuwahara M | 17-22 |
| Statistical Consideration | Uesaka H | 23-30 |
| Cost-Trends: Comparison of the Cost; Japan vs. Rest of the World Including Asia | Shimatani K | 31-40 |
| Panel Discussion | 41-52 | |
| SESSION 2: REGULATORY UPDATES AND CLINICAL TRENDS | Chairpersons: Fujiwara Y Takeuchi M | 53-126 |
| Review of Bridging Programs, Regulatory Successes | Todaka K | 55-66 |
| A Case Study in the Value of Harmonisation | Hayashi Y | 67-75 |
| Panel Discussion | 77-84 | |
| Large Scale Clinical Trial Network | Hirota M | 85-91 |
| Industry Performance Metrics: How Does Japan Compare with the West? Are things Improving? | Walker SR | 93-104 |
| The Internet as a Means of Recruitment, Patient Education, Data Management and Monitoring | Wilson SE | 105-16 |
| Panel Discussion | 117-26 | |
| SESSION 3: PRACTICAL USE OF ICH GUIDELINES FOR BRIDGING/
GLOBAL CLINICAL TRIALS; ICH E5 Q&A (TV-Conference) | Chairperson: Lagakos SW | 127-57 |
| The ICH E5 Question and Answer Document: Status and Content | O'Neill RT | 129-33 |
| Bridging Studies in Vaccines Research | Ellenberg SS | 135-41 |
| How Should We Plan and Conduct Asian Studies? -From the Reviewer's Viewpoint- | Mori K | 143-8 |
| Panel Discussion | 149-57 | |
| SESSION 4: OMICS: GENOMICS, PROTEOMICS AND METABOLOMICS
-How Can They be Used to Enhance Product Approval?- | Chairperson: Arai K | 159-210 |
| How Has OMICS Influenced Paradigms? -How Can They be Used to Enhance Product Approval?- | Power AC | 161-75 |
| Japan Perspective on PGt/PGx in the Drug Development and Approval Process | Azuma J | 177-87 |
| Japan Issues and Counter Measure for Real Implementation of Genome Based Clinical Trials | Yasuda S | 189-97 |
| Panel Discussion | 199-210 | |
| SESSION 5: OTHER NOVEL TECHNOLOGY UPDATE:
MODELING TECHNIQUE, BIOMARKERS, DISEASE SURROGATES, DATA MINING | Chairperson: Imura H | 211-62 |
| Modeling Technique: Structual Cenomics/Structual Proteomics | Nakamura H | 213-20 |
| Biomarkers and Medical Imaging in Clinical Trial | Carter WO | 221-32 |
| Application of PK/PD Modeling in Drug Development | Sharma A | 233-41 |
| Bridging Strategies Using Clinical Trial Simulations | Wada RD | 243-51 |
| Panel Discussion | 253-62 | |
| SUMMARY AND CONCLUSION | 263-74 | |
| Summary and Conclusion | Lagakos SW | 265-71 |
| Closing Remarks | Takeuchi M | 273-4 |
| QT Symposium(Satellite Meeting) | 275-329 | |
| Opening Remarks | Takeuchi M | 277 |
| Topic 1: Non Clnical Pharmacology and Clinical Assessment of QT Prolongation | Chairperson: Takahashi K | |
| Non Clinical Pharmaclology; To Cover Testing Paradigms and Latest ICH Thinking(ICH S7B) | Robert Wallis | 279-95 |
| Clinical Assessment of QT Prolongation | Sase K | 297-306 |
| Topic 2: The Link Between Non-Clinical and Clinical Testing | Chairperson: Sase K | |
| The Link Between Non-Clinical and Clinical Testing | Perkins MC | 307-20 |
| Wrap Up and Conclusion(Panel Discussion) | Chairperson: Perkins MC | 321-9 |