Ms.Noriko Fujiwara, MS,RN,OCNS,CCRP works as a research nurse and a project researcher 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 the Project Management Certification Program at UCSD, CA, USA in 2016, and a research internship at MD Anderson Cancer Center, TX, USA. She is currently a president of the Japan chapter of the International Association of Clinical Research Nurses (IACRN), a member of the Research Nurse Committee of Gynecologic Oncology Trial and Investigation Consortium (GOTIC), and an operational chair of Asia-Pacific Gynecologic Oncology Trials group (APGOT).

Ms. Nao Horie is a Project Manager for Investigator-initiated Study at Clinical Research and Medical Innovation Center at Hokkaido university hospital institute of health science innovation for medical care(HELIOS). Ms.Horie is a pharmacist and has over 15 years of experience in working as a Clinical Research Coordinator (CRC), Data Manager and Project Manager at HELIOS. Ms. Horie became interested in clinical development when she was working as a pharmacist, and shifted her career to CRC. To further pursue her career, Ms.Horie completed the master's program in clinical development at the graduate school while working as a Project Manager, and obtained a Master of Medical Science from Hokkaido University.

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.

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.

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.