About This Event

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.  Workshop will be translated English to Korean to English.

Highlights include:

• Sessions on platform strategies and comparability for CGT products
• Global regulatory perspectives and panel discussions
• Real-world case studies from industry leaders
• Networking opportunities with experts from the industry and regulatory bodies.

Please note that we will provide interpreters in person for this event (English-Korean).