11th Annual Outsourcing in Clinical Trials & Clinical Trial Supply Korea 2026
Keynote Stream A: Outsourcing & Clinical Operations track
KEYNOTE: US FDA Entry Strategy in 2026: How Korean Biotech Should Approach the US Market
Wed, Dec 2, 2026 · 4:45–5:15 PM KST JW Marriott Dongdaemun Square Seoul
About this session
Global market trends and US FDA regulatory perception. Establishing a strategy for New drug development in line with updated guidance from US FDA. FDA engagement strategy: pre-IND/IND and accelerated clinical programs.
