Hiroshi Yamazaki is a Senior Manager in Global Epidemiology within the Office of the Chief Medical Officer at Johnson & Johnson Innovative Medicine. Based in Japan, he leads and supports real-world evidence (RWE) generation and regulatory engagement across therapeutic areas. He holds an MSc in Population Health Sciences from University of Glasgow and a pharmacist license, and his research interests include pharmacoepidemiology, regulatory science and regulatory application of RWE.

Suguru Okami, Ph.D., RPh, is Director and Head of Integrated Evidence Generation at Bayer Yakuhin, Ltd. in Japan, where he also serves as post-marketing surveillance controlling manager within Medical Affairs and Pharmacovigilance. With more than a decade of experience in observational epidemiology and post-marketing research, he leads a team responsible for real-world evidence generation across the product lifecycle, spanning study design, regulatory-driven evidence planning, and Good Post-Marketing Study Practice (GPSP). His work focuses on leveraging real-world data to support safety evaluation and regulatory decision-making, particularly in cardiovascular, renal, and metabolic diseases. He holds a Ph.D. in Systems Engineering from Keio University and a pharmacist license, and his research interests include database research, medical geography, and applications of data science and artificial intelligence to evidence generation. He is an active member of the Japanese Society of Pharmacoepidemiology, ISPOR, and IEEE.

Dr. Ju-Young Shin is current professor of college of pharmacy, Seoul National University (SNU). She also serves as an associate editor of ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health’. She received her B.S. in pharmacy from Seoul National University, MPH in health policy and Ph.D. in pharmacoepidemiology from the Seoul National University College of Medicine. She was working as a director at Korea Institute of Drug Safety and Risk Management (KIDS), university of South Australia as a visiting fellow, McGill University as a postdoctoral fellow and Sunkyunkwan University (SKKU) as a professor and department chair. She is currently a member of board of directors of Korea society of Pharmacoepidemiology, society of social pharmacy, and of regulatory Science.

Qingqing Hu, MD, PhD, is an Associate Director in Global Epidemiology within the Office of the Chief Medical Officer at Johnson & Johnson Innovative Medicine. Based in Shanghai, she leads solid tumor epidemiology and real-world evidence (RWE) initiatives in China, supporting drug development, regulatory strategy, and risk management. She has contributed to approximately 30 scientific abstracts presented at major international conferences, including ASCO, ESMO, ISPE, and ACPE, and has authored publications in solid tumor research. Dr. Hu earned her PhD in Cancer Epidemiology from the University of Utah. Her research interests include pharmacoepidemiology, oncology outcomes research, and the application of RWE in regulatory and clinical development. Dr. Hu is dedicated to advancing evidence generation to support innovative medicines and improve patient outcomes.

K. Arnold Chan is a pharmacoepidemiologist with almost 40 years of global research experience in North America and East Asia. He received medical training at National Taiwan University and advanced epidemiology training at Harvard School of Public Health. He subsequently served as faculty in both institutions. His private sector experience includes positions in a global pharmaceutical company and a service provider. He has authored or co-authored more than 160 original research articles and co-edited a textbook on Pharmacoepidemiology and Therapeutic Risk Management, with an H-index of 62 according to Google Scholar (August 2026). He is a member of the first cohort of FISPEs, who were inducted in 2003. Dr. Chan is currently a Senior Vice President at TriNetX LLC.