Kasumi Daidoji is an Associate Director of Clinical Planning and Development Department, Medical HQs at Eisai Co., Ltd. After graduating from the master course at faculty of pharmaceutical sciences, Tokyo University of Science, she joined Eisai. She has over 20 years’ experience in statistical analysis of clinical trials, observational studies and pharmacovigilance. Now she is mainly responsible for pharmacoepidemiologic research and post-marketing database study using large-scale hospital administrative database / health insurance claims database. In addition, she supports Student Activities in DIA Japan this year.

Tempei Miyaji is currently a Project Assistant Professor at Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, a Project Researcher at Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, and a Part-time Lecturer at Division of Biostatistics, Tohoku University Graduate School of Medicine, Japan. He is also a program committee member of DIA Japan Annual Workshop For Clinical Data Management. He has 10 years experiences conducting clinical data management especially in the field of oncology, supportive care and palliative care. His research interests include risk-based monitoring, patient-reported outcomes research and mobile Health.

Shintaro Hiro, PhD, has over 15 years of experience as a project statistician in the pharmaceutical industry. Currently, he holds a managerial position of Data Science & Analytics Japan Lead within the Statistical Research & Data Science organization at Pfizer R&D Japan. In this role, he supports Pfizer colleagues with utilization of real-world and aggregated data to generate evidence for clinical development and for post-approval activities.

Dr. Daisuke Koide is Project Professor at the Department of Biostatistics and Bioinformatics at Graduate School of Medicine, the University of Tokyo. He is also head of safety information division at clinical research support center in the University of Tokyo Hospital. He holds a pharmacist license, and a doctorate in health science from the University of Tokyo. For over twenty years, his work has focused on pharmacoepidemiology and health informatics. He has served as vice president of Japanese society for pharmacoepidemiology and councilor of Japan Association for Medical Informatics.

Dr. Toshifumi Sugitani is currently a Director of RWE at Syneos Health Japan. He has a PhD in Biostatistics. Toshi’s area of expertise span across statistical methodologies in confirmatory clinical trial designs (e.g., Graphical approaches, Adaptive designs), dose-response studies (e.g, MCP-Mod), observational studies, real-world studies and evidence generation using large healthcare databases in Japan (e.g, MDV, JMDC, C-CAT), patient-preference studies, and marketing science for sales data in pharma industry in Japan. He is the lead or co-author of more than 20 peer-reviewed publications in statistics or medical journals. He received a Research Encouragement Award from the Biometric Society of Japan in 2020.

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a visiting professor in Chiba University and Nagoya University.

Mr. Takeshi Adachi is CEO of PPG inc. (Regulatory Consultation Farm) and former ICH-M2 expert and Topic leader during 2003-2011. Mr Adachi was head of regulatory Affairs of Janssen Pharmaceutical K.K. and he had over 30 years’ experience of pharmaceutical product development. He also was Deputy-Head of pharmacovigilance of Sanofi-Aventis. He had contributed eCTD implementation in Japan and collaborate with MHLW/PMDA, and leaded Japanese pharmaceutical industries electronation including EDC, eICSR, DMS etc. Mr. Adachi is continuing pharmaceuticals, re-generative medicine and medical device development as regulatory consultant and also electronic system implementation as IT consultant at his company.

Mr. Rei Maeda is currently a contractor of Eli Lilly Japan., working for Global Patient Safety and Solution. Mr. Maeda has around 20 years' each experience both in pharmaceutical development area and postmarketing safety area. Recently he has been focusing on Safety Risk Management matters including postmarketing real world data/evidence utiliztion both from each product and from regulation point of view. Mr. Maeda has some roles i.e., PhRMA Japan Safety leader, a member of FPMAJ safety working teams, and a member of AMED RMP investigation group. Mr. Maeda graduated from Kyoto Phrmaceutical University and has a licence of pharmacisit. Also he is a recipient of the "DIA Excellence in Service Award 2018".