15th DIA Japan Annual Meeting 2018

Since ICH E 6 (R2) requires new responsibilities for Sponsors, each sponsor organization has to implement new measures and efforts for QMS. Although the current implementation is still trial and error at the field level, the majority of clinical trial operational staff at most companies have still not fully understood the fundamental concepts of QMS. In this session, from the standpoint of the regulatory authority, they will explain the purpose and requirements of the QMS implementation, and from the point of view of the sponsor, they will introduce the proper method for implementation using PMBOK Guide (Project Management Body of Knowledge) and others in Risk Management and Quality Management / Quality Management System (QMS)