CMC Strategy Forum Japan
Event Dec 04 - Dec 05, 2017
Location: Tokyo, Japan
CASSS’ CMC Strategy Forum Japan will be held 4-5 December 2017 in Tokyo. The Forum will 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 and Health Canada. Other regulatory agencies that have been invited include China, Korea and Thailand. The technical sessions will include discussions on Recent Trends in the Regulation of Biopharmaceutical Products, ICH Q12 Update, Challenges in Global Development of Drug Device Combination Product and Use of Prior Knowledge to Support CMC Development in Conventional and Expedited Settings.
The CMC Strategy Forum has established an excellent reputation for being the premier scientific meeting that brings together regulatory, industry, and academic professionals to discuss key emerging CMC issues that affect biotechnology in an open and transparent workshop format.