CMC Strategy Forum Japan,
03 Dec 2012 - 04 Dec 2012 - Tokyo, Japan
We are very pleased that with the strong support from the Pharmaceuticals and Medical Devices Agency (PMDA, Japan), as well as the Japan Pharmaceutical Manufacturers Association (JPMA), and with the continued sponsorship by CASSS and the United States Food and Drug Administration, that we are launching the CMC Strategy Forum Japan 2012. 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, KFDA, SFDA, as well as HSA. The technical sessions will include discussions on biosimilars, glycosylation control and structure-function relationship, as well as a brief session on QbD for biologics.
With this exciting program, I would like to extend to you an invitation to attend and participate actively in making this landmark meeting a great success.