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.

Ms.Noriko Fujiwara, PhD,RN,OCNS,CRN-BC works as a research nurse and an advanced practice nurse for the department of palliative medicine and advanced clinical oncology, IMSUT hospital of the Institute of Medical Science, the University of Tokyo, JAPAN. She completed her research nurse internship at MD Anderson Cancer Center, TX, USA in 2016. Currently, she serves as a board member of the International Association of Clinical Research Nurses (IACRN) and as the Nursing Co-Chair of the International Gynecologic Cancer Society (IGCS).

Yoko Kazami is a project manager, who has worked for Nobelpharma Co., Ltd. from January 2017. She has over 15 years' experience in Japanese pharmaceutical companies and Academia research organizations. She is also a member of DIA Project management community in Japan, and plans and conducts some PM training course. She obtained her B.S. in Pharmacy from Showa University, 1997.

Kayoko Kikuchi is in Development Office for Translational Research, Fujita Health University. She has been working as PM for investigator-initiated clinical trials for over 10 years . She has a background in clinical operation and drug development for 10 years in the pharmaceutical companies. Additionally, she has over 2 years' experience in CNS area as a CRC. She graduated from Tokyo Science University and received Ph.D. in Medicine from Keio 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.

Prof. Kotone Matsuyama is currently Professor, Department of Health Policy and Management, and Vice President of Center for Strategic Research Initiative, Nippon Medical School. Professor Matsuyma graduated from Kyoto University Faculty of Pharmaceutical Science and obtained a license as Pharmacist. She started her Research and Development (R&D) career as a data manager in 2003 and she has worked as a project manager since 2005. She spent 12 years at the Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, and 2.5 years as a Lecturer at the Center for Quality Assurance in R&D, Kyoto Prefectural University of Medicine.

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.

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.

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.