Dr.Koji Iwasaki is the Professor of Academic Clinical Research Center, Osaka University Hospital. Dr. Iwasaki is incharge of progress of clinical research, specially, building the strategy, clarify the hypothesis and creating the protocol for clinical trial with investigators in reserch team. Dr. Iwasaki has over 30 years' clinical development experience in the pharmaceutical company, including clinical research and reguratory science. Dr. Iwasaki has experience in setting up medical affairs departments in pharmaceutical companies and he is the organizer of the Medical Affairs Certification Training Program of the Regulatory Science Foundation. Dr. Iwasaki holds a PhD in Pharmaceutical science from Kyoto Pharmaceutical University.

Mr. Koichi Konno is a chief executive at PM consulting Positive Intention. Mr. Konno has started his career as a consultant of project management in 2013. He has over ten years of experience as a manager of PMO, after 10 years of working as a leader of clinical study in a pharmaceutical company. Mr. Konno holds certification of Project Management Professional (PMP) and he is a lead of Project Management Community of DIA Japan.

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 admin function. Before these works, he led 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.

Mr. Shuji Sumida is Senior Director, HR Business Partner of Quality & Regulatory Compliance Unit at CHUGAI PHARMACEUTICAL CO., LTD. In this position, Mr. Sumida is a responsible person for HR strategy containing hiring, rotation and carrier development in that division. Mr. Sumida has over 35 years' experience in the pharmaceutical industries, including Formulation Technology, Project Management, and Quality & Regulatory Compliance. Mr. Sumida holds a MSc in Pharmacoscience from Tokyo University of Science and a Project Management Specialist from PMAJ.

Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects (RA strategy & operation). He has been global project manager for nearly 20 years (in JPN & US) and the head of PM office in Daiichi Sankyo Japan for 3 years. He has been an active volunteer to both DIA global and Japan, playing session chair roles in global annual meeting more than 10 times, and was the vice-chair for 13th DIA Japan Annnual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.

Mr. Noriaki Nagao is Clinical Quality Management Team Leader at Clinical Development Dept. Pharmaceutical Division JAPAN TOBACCO INC. In this position, Mr. Nagao is responsible for keeping and managing quality of conducting clinical trials in this organization, including GCP training , document management, document check, and SOP management and so on. Mr. Nagao has 16 year' experience in the Pharmaceutical industry, including CRA and quality management. Mr. Nagao holds a PMP certified by Project Management Institute, and holds a MPharm in Tokyo University of Pharmacy and Life Sciences.