Workshop Open to Industry and the General Public
Join global experts, regulators, and industry leaders for a two-day workshop focused on Chemistry, Manufacturing, and Controls (CMC) considerations for biotechnology and advanced therapy products (ATPs). Co-hosted by USP and NEU under the APEC Center of Excellence for Advanced Therapies, this event will explore the evolution from traditional biologics to cutting-edge gene and cell therapies from a CMC perspective. Attendees will gain insights into regulatory expectations, comparability approaches, platform strategies, and the challenges of global harmonization.
This workshop is ideal for regulatory professionals, CMC scientists, and developers of advanced therapy products seeking to stay ahead in this rapidly evolving field. The workshop will be translated English to Korean to English.
View the agenda
Day One: Wednesday, October 1, 2025
Day Two: Thursday, October 2, 2025