| · Cultivating trust and shared value through End-to-End clinical supply chain collaboration
· Creating effective communication channels to enhance transparency and strengthen trust · Aligning incentives between sponsors and vendors to prevent supply shipment delays |
Archives: Agenda
KEY NOTE: Ensuring Safe and Efficient Clinical Supply Management in Global Trials: Practical Strategies and Optimization Approaches
• Real-world challenges in IP (Investigational Product) supply management – balancing safety, compliance, and cost in global trials
• Adaptive strategies to prevent stockouts and manage variable recruitment
• Enhancing operational efficiency through optimized IRT configurations
• Leveraging modeling and simulation tools to forecast demand and reduce waste
Afternoon refreshments and networking
Streamlining Success: An Integrated Approach to Clinical Quality Assurance in Supply Chains
| · Regularly auditing suppliers and manufacturing partners to ensure compliance with regulatory standards
· Conducting regular training and workshops to align all parties on quality assurance standards and practices · Developing and maintaining detailed risk management plans |
Enhancing Drug Forecasting to Reduce Waste and Optimize Supply Chains
• Challenges in Clinical Drug Supply Management
• New Technologies in Clinical Drug Supply Management
• Global Case Studies & Best Practices
Optimizing Central Lab Supply Chains: Overcoming Logistical Barriers in Clinical Sample Management
| · Addressing challenges in collection, labeling, packaging, and international shipping
· Ensuring cold chain integrity to maintain sample viability and data accuracy · Navigating cross-border requirements, permits, and documentation delays |
Lunch and networking
GMP and Global Trials: Managing Multi-Regional Requirements for Manufacturing
- Understanding Data Integrity (DI) for Effective GMP Management in CMO/CDMO
- A Trend of Parametric Release Criteria for Aseptic Drug Production by MFDS (Korean Food and Drug Administration)
Localising clinical trial supply in (J)APAC: Risk, resilience, and revenue
With JAPAC now the fastest-growing clinical trial region, sponsors need local supply strategies to de-risk programs and improve patient access. This session explains the necessity of building resilient, compliant local supply networks and the commercial upside for manufacturers and CROs across and within JAPAC
- Why JAPAC matters now: JAPAC trial activity is accelerating vs. other regions, major growth in China and parts of Asia(https://www.reuters.com/business/healthcare-pharmaceuticals/china-pharma-firms-turn-local-reagent-s…)
- Supply risk: reliance on Europe/US creates delays and vulnerability: Local sourcing reduces lead times and tariff risk (recent moves to local reagents/manufacturing)(Reuters)
- Practical actions: rapid tech-enabled cold chain, local comparator sourcing, in-region labelling/regulatory templates and contract manufacturing partnerships
Advancing Adaptive Strategies for Clinical Trial Supply Manufacturing
| · Strategies for just-in-time manufacturing to reduce inventory and waste
· CMO Selection: Aligning Partner Capabilities with Evolving Clinical Supply Demands · Modernizing the Supply Chain: Evaluating and Adopting Next-Generation Manufacturing Solutions |