Dr. Hirotaka Inoue is Head of Leading Changes Office at GlaxoSmithKline KK. In this position, Dr. Inoue is responsible for leading enterprise business improvement and change management initiatives. Dr. Inoue has experiences in drug discovery, clinical development, project management and an internal consultant in change management. Dr. Inoue holds Ph.D in Pharmacology, MBA and a master black belt of Six Sigma. Dr. Inoue is a committee member of ISO18404 (an international standard with Six Sigma)

Dr. Yoichi M. Ito is an professor of Hokkaido University Hospital. He is engaged in a special commttee member of PMDA since 2012. He holds a phD in Health sciences from Tokyo Univerisy and his speciality is biostatistics.

Naoko Hagimori is a project manager and study manager for clinical trials at the Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe. Naoko Hagimori is responsible for as a teamleader.Naoko Hagimori has over 15 years’ experience as a Clinical Research Coordinator and pharmacist. She holds a PhD in Environmental Science from Nagasaki University and is certified as an ARO Council Certified Study Manager and JSCPT Certified Clinical Research Coordinator.Naoko Hagimori is a graduate of Meiji Gakuen in Kitakyushu, Japan.

Ms. Yuki Sasaki is a Clinical Trial Coordinator at Hokkaido University Hospital. Since 2012, Yuki has served as the Director of the Clinical Trial Site Management Office, where she has been involved in CRC education and the clinical trial process. In 2016, she also took on the role of Director of the Office of Human Subjects Protection. Additionally, she has been engaged in the educational activities of ARO's CRC as a representative of the ARO Council CRC Professional Liaison Committee since 2019. In 2018, she earned her Master of Business Administration degree with a major in Entrepreneurship from Otaru University of Commerce. She promotes quality management within the organization while ensuring patient safety and staff work efficiency.

Hisako Kobayashi is a Clinical Research Coordinator at Osaka Keisatsu Hospital. In this role, she provides a wide range of trial support for corporate clinical trials, investigator-initiated clinical trials, and clinical research. Hisako Kobayashi is a licensed pharmacist, but has over 20 years of experience in the clinical research coordinator industry. She has not received any awards.

Takashi Sato has worked in research and development division of a pharmaceutical company for more than 30 years, and currently belongs to the planning and administration function. Before these works, he led Global Project Management Office and had work experience in clinical operations, and as a pharmacovigilance specialist in clinical studies. Besides his works in the company, he run his private business since 2021. He serves training for project management, consultations, and coaching in his business. Takashi Sato is Project Management Professional certified by Project Management Institute. Also, he is a Certified Professional Co-active Coach by Coach Training Institute.