11:00 AM - 11:30 AM ET
Including Japan in global trials: New PMDA rules and DC office support
Nikkei Biotech’s Aya Kubota will interview Dr. Yasuhiro Fujiwara, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Dr. Akihiro Ishiguro, Head of the PMDA Washington D.C. Office, about the agency’s updated guidance that allows Japan to participate in certain multinational studies without a separate Phase 1 in Japanese volunteers when predefined conditions are satisfied. The speakers will explain the specific data requirements behind this policy change and describe how sponsors can use the new Washington office to schedule consultations, request scientific advice, and stay informed throughout the submission process.