CMC Strategy Forum Japan 2013
09 Dec 2013 - 10 Dec 2013 - Tokyo, Japan
A warm welcome to the second meeting of the CMC Strategy Forum Japan 2013 which will be held in Tokyo, 9 - 10 December 2013.
The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Japan and Asia and will feature an opening regulatory session that will include presentations from PMDA, FDA, EMA, MFDS, as well as HSA and India. The technical sessions will include discussions on post-approval change control of biopharmaceuticals, new technology of antibody engineering with focus on antibody drug conjugates, control strategies of aggregates and particles in biopharmaceuticals, as well as a session on a QbD application bringing together global and Japan specific case studies.