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.

Kotone Matsuyama is Director of the Center for Clinical Research at the National Center for Child Health and Development, Japan, and President-Elect of IFAPP. She also serves as Chair of the DIA Japan Contents Committee and Lead of the IFAPP Bioethics Community. An IFAPP-certified Global Fellow in Medicines Development (GFMD) and board-certified specialist in pharmaceutical medicine, she specializes in pharmaceutical medicine, clinical pharmacology, clinical trial management, product development, and research ethics. Her work focuses on advancing clinical research, patient engagement, regulatory science, organizational governance, and academia-industry collaboration, with a particular emphasis on pediatric and maternal health.

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 brings over 30 years of pharmaceutical R&D experience to his current role supporting translational research as an ARO Project Manager. With a background in discovery research, clinical pharmacovigilance, and CRA field operations at pharmaceutical companies, he leverages deep practitioner insights to manage complex development projects. Holding both PMP and CPCC credentials, he combines project management methodology with certified executive coaching. As an independent practitioner, he offers specialized PM training, consulting, and one-on-one coaching.

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.