- 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
- Checking out what’s working and what could be better
- Looking at the difference between research done purely for research versus for commercialization, and what that means for patients given today’s
- How the growth of domestic Korean CROs is reshaping vendor selection
- Supply chain capability comparisons between local and global CRO, CMO, CDMO offerings
- Where domestic CROs are closing the gap on international standards
- Addressing common operational and scientific challenges in Phase 1 and Phase 2 trials
- Managing complex protocol designs incorporating biomarkers and adaptive trial elements
- Evaluating the necessity of placebo groups in Phase 1 studies
- Embedding QbD principles across the clinical supply lifecycle to proactively manage risks
- Strengthening risk-based quality management for compliance and supply continuity
- Preparing quality-driven supply strategies for advanced therapies and complex trials
