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)

Mr. Kazuhiko Kamiyama is Director of Project Leadership, direct and manage assigned team of clinical project management staff who manage or support studies or programs to ensure quality, time, and budget deliverables are met to the Sponsor's satisfaction. Before then he worked at Pfizer 17 in years and also worked at BMS and GSK. He has been working on clinical development area starting from CRA, Lead CRA, Monitoring Team Leader, Study Manager and People Manager. The drug therapeutic areas experiencing were Cardiovascular, Endocrinology, Gastrointestinal, Infection, Neurology, Oncology(Longest), Orthopedics and Psychiatry. He was also a member of DIA Six Sigma community and JPMA Clinical Evaluation Expert Committee.

Currently working for Biometrics & DM, Pfizer R&D Japan as the Data Quality Lead. She also engage HL7 Vulcan as a Operation Committee memebe. She is also a member of TransCelerate Japan Clinical Networ, specially advocating Process Harmonization like Dgital Data Flow etc in Japan. As a part of her responsibilities in Pfizer, she has worked for the eSource project in Japan which is a part of the global pogram. She has over 25 years' experience in Pharmaceutical industry and mostly served data management and clinical study data related activities.