返回 Agenda
Session Chair(s)
Satomi Ando, MSC
Manager, Clinical Research & Medical Development Center
Japanese Foundation For Cancer Research, Cancer Institute Hospital , Japan
Speaker(s)
Aim for Simultaneous Approval Beyond Simultaneous NDA from CTD Author’s Perspective
Yoko Hirano, MSC
Pfizer Japan Inc., Japan
Through Experience of Global Simultaneous Submission, Review, and Approval - Changing and Expanding Possibility of Medical Writer’s Role
Ayako Sato, MA
Novartis Pharma K.K., Japan
RA Functions Department
Reviewer Perspective for Global Simultaneous Submission and Approval
Aki Nakai
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director for Personnel Coordination, General Affairs