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. SENGA is a Principal Inspector of Office of Non-clinical and Clinical Compliance I at PMDA, Japan. Mr. SENGA is responsible for conducting document-based inspection and GCP on-site inspection. Mr. SENGA has over 10 years' experience as an inspector and a reviewer in PMDA.

Yujiro Nonaka holds a pharmacist license and works as a regulatory consultant with broad experience in clinical research and regulatory operations. He currently supports PMDA consultations for both drugs and medical devices at A2 Healthcare Corporation. His previous roles include Study Manager and Clinical Research Coordinator at Gifu University Hospital, and Inspector and Reviewer at PMDA, where he was involved in GCP/GPSP inspections, clinical trial notifications, and new drug application reviews. He has worked across a wide range of therapeutic areas including oncology, infectious diseases, and ophthalmology.