Archives: Agenda
REGULATORY SPOTLIGHT: Understanding duty and entry rates in US clinical supply chain imports!
- Optimize clinical trade compliance by ensuring precise material classification and valuation
- Collaborating with brokers and logistics partners to ensure compliant, efficient
- importation
- Determining duty rates and entry rates for different types of clinical trial materials and products
- Applying for duty exemptions: are you eligible?
INTERACTIVE PANEL DISCUSSION: How to stay GMP-compliant while optimizing QP resources, quality processes, and regulatory alignment 📊 LIVE POLL
- How to plan and allocate resources effectively across the full study lifecycle (from manufacturing to release and distribution)
- How to prepare for audits and inspections proactively incorporating audit readiness into daily workflows to avoid last minute firefighting
- The value of leveraging external partners and CDMOs effectively to improve quality oversight with limited internal teams
DESIGNED FOR THE PATIENT
🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝
AI is powerful, but the drug and the patient come first. This boardroom explores how teams can leverage AI safely, integrate it into workflows, and maintain human control with strong processes.
Outcome: Each table will collaborate to create practical strategies, and governance approaches that balance AI capabilities with human oversight, ensuring AI enhances decisions rather than replacing critical thinking.
A variety of alcoholic and soft drinks will be served
🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝
AI is powerful, but the drug and the patient come first. This boardroom explores how teams can leverage AI safely, integrate it into workflows, and maintain human control with strong processes.
Outcome: Each table will collaborate to create practical strategies, and governance approaches that balance AI capabilities with human oversight, ensuring AI enhances decisions rather than replacing critical thinking.
A variety of alcoholic and soft drinks will be served
Ready Teams, Successful Trials
AI with a Human Touch: Practical Strategies for Smart, Safe Adoption
INTERACTIVE PANEL DISCUSSION: “Silo Effect” – How to turn disconnected functions into a unified strategy that accelerates clinical supply and improves patient experience 📊 LIVE POLL
- How to reposition CTS from a pure logistics function to a strategic partner and enable teams to advocate their value internally to improve ClinOps outcomes
- Protocol vs. Reality: How to close the gap between protocol design and operational reality through early collaboration to ensure the supply chain matches the realities of patient care
- How to establish shared goals, KPIs, and communication frameworks between CTS and ClinOps to sustain alignment and ongoing collaboration throughout the study
CASE STUDY: The 72-Hour Pulse: How Orca Bio is Using AI to Erase Risk and Guarantee Patient Delivery 📊 LIVE POLL
- How to safeguard temperature-sensitive biologics and advanced therapies during shipping delays
- How to stay compliant with local and global regulations while maintaining chain-custody
- How to select validated storage facilities for all temperature ranges while keeping inventory visible and minimizing loss