Thursday, October 5, 2000 - Friday, October 6, 2000 (Tokyo)
Contents Table for Abstracts and Electronical Slide Presentation

PREFACE

Stephen W. Lagakos, Ph.D.1) and Masahiro Takeuchi, Sc.D.2)
1) Harvard School of Public Health, 2) Kitasato University Graduate School

GLOBAL HARMONIZATION

Global Harmonization and the Achievements of ICH
Dr. Elaine C. Esber (U.S. Food and Drug Administration)

Impact of ICH Prosess and Guidelines
Dr. Keiji Ueda (Tokyo Metropolitan Tama Geriatric Hospital,The Organization for Pharmaceutical Safety and Research)

ETHNIC DIFFERENCES
Drug Metabolism
Interethnic Differneces in Drug Metabolism
Prof. Takashi Ishizaki (Kumamoto University)

Disease Presentation West vs East
Cardiovascular Disease in Asia: Mortality and Risk Factors
Dr. Jiang He (Tulane University)

Dose Setting
Significance of Dose Setting Studies in the Bridging Study Strategy
Dr. Chikayuki Naito (Tokyo Teishin Hospital,The Organization for Pharmaceutical Safety and Research)

BRIDGING STRATEGIES
Bridging : Efficacy and Safety
Bridging: Efficacy and Safety
Prof. Shinichi Kawai (St. Marianna University School of Medicine)

Bridging : Methods and Special Populations
The Challenge of Bridging
Prof. James H. Ware (Harvard School of Public Health)

Bridging: Statistical Considerations
Statistical Issues on Bridging Studies
Prof. Masahiro Takeuchi (Kitasato University Graduate School)

Methodological Issues in Evaluation of Bridging Evidence for Pharmaceutical Products
Prof. Jen-Pei Liu (National Health Reseach Institutes, Taiwan)

Bridging Guidance
Bridging Guidance
Dr. Yoshinobu Hirayama (Pharmaceuticals and Medical Devices Evaluation Center)

FUTURE STRATEGIES AND CHALLENGES
Bridging Western Data to Japan
Bridging Western Data to Japan
Prof. Fumihiko Sakai (Kitasato University)

Bridging Japanese Data to the West
Bridging Japanese Data to the West
Dr. Richard Pazdur (U.S. Food and Drug Administration)

Depression: Western and Japanese Differences
Depression: Western and Japanese Difference
Prof. Kunitoshi Kamijima (Showa University)