- Unpacking the challenges and complexities inherent in the full pharmaceutical supply chain journey, from production to final patient delivery
- Navigating regulatory demands and ensuring ongoing compliance across the chain
- Reviewing the practical strategies used to enhance performance and quality across the entire supply chain
- Identifying the right point for CRO involvement to improve efficiency and execution
- Leveraging CRO insights to optimize protocol design, country selection, and study feasibility
- Establishing clear communication, shared accountability, and collaborative ways of working
- 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
