3rd DIA Lifecycle Management Workshop in Japan
- Global Patient Safety and Solutions
- Eli Lilly Japan K.K., Japan
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".
- Takeda Pharmaceutical Company Limited, Japan
Shintaro Hiro, PhD
- Manager, Data Science & Analytics Japan Lead, Clinical Statistics
- Pfizer R&D Japan, Japan
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.
Daisuke Koide, PhD, RPh
- Project Professor, Department of Biostatistics and Bioinformatics
- Graduate School of Medicine, The University of Tokyo, Japan
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.
Taichi Nakamura, MD, PhD
- MS Lead
- Japhmed, Japan
- Founder and CEO
- PPG, Japan
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.
Yoshiaki Uyama, PhD, RPh
- Director, Office of Medical Informatics and Epidemiology
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference on Harmonisation Technical Coordinator; as ICH E15 and E16 topic leader; as Division Director, Regulatory Science Research; as Division Director, Review Planning and Pharmaceutical Affairs Consultation; as Director, Division of Epidemiology; and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group.