19th Annual Workshop in Japan for Clinical Data Management

There is an increasing focus on having Clinical Quality Management Systems (QMS) in place for clinical research. Regulatory agencies have also expressed interest in this topic and they are increasingly speaking about the importance of sponsors’ QMS in clinical research, and of the shifting expectations for sponsors’ clinical study oversight, in particular to a quality risk management approach in study oversight. In this session, we will learn what regulatory agency think about QMS for clinical research considering a revision of ICH E6 being discussed and the largest section of change to E6 is the new sponsor responsibility section 5.0 on Quality Management. There will be some challenges we deal with when implementing QMS. We will also been given a sense of what we can do to contribute to QMS planning and its implementation as Data Expert.