Archives: Agenda

• Aligning Supply Chain, CMC, Clinical Operations, Regulatory, Quality, and Finance to evaluate options, trade-offs, risk, and cost and align on an integrated path forward
• Establishing S&OP governance, ownership, and decision rights linking supply execution with financial planning to drive transparency, accountability, and aligned decisions
• Creating end-to-end visibility to identify constraints early, improve agility, mitigate risk, and maintain supply continuity across clinical and commercial programs

• From forecasting to continuous supply intelligence: why the real metric is decision latency, the time between a supply signal and a supply action, and how leading sponsors are collapsing it from weeks to hours

• The connected ecosystem in practice: how event-driven supply orchestration (IRT working in concert with eCOA, depots, couriers, and temperature data) turns thousands of small, automated decisions into fewer shipments, leaner stock, and uninterrupted patient dosing.

• You vs. the algorithm (live)

• Understand current importation requirements and regulatory considerations for pharmaceuticals, biologics, medical devices, and combination products used in clinical research.

• Learn practical strategies and best practices to prevent shipment delays, mitigate compliance risks, and maintain continuity of clinical trial supplies across global supply chains.

• Explore how to navigate the FDA imports process from entry submission to compliance determination

🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

• How to make sure you are building accountability and reconciliation practices into the study planning up front, before the first shipment is dispatched
• How to clearly define the accountability process and primary system of record to ensure sites and CROs understand expectations for documentation, reconciliation and destruction
• How to standardize site-level data capture while accommodating local practices to prevent mismatches and delays at study closeout
• How to leverage electronic systems to embed audit-ready accountability into daily workflows, shifting from reactive clean-up to real-time documentation
• How to ensure a controlled IRT closure that eliminates discrepancies and supports complete, audit-ready records that helps you to save money in the long run

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• China’s Rise as a Clinical Trial Hub: How rapid patient accrual, cost advantages, and government support are diverting early-phase development offshore
• The Global Regulatory Reality: Navigating FDA expectations for multi-regional data while leveraging overseas trial efficiency
• Western CRO Competitiveness: Adapting to aggressive competition from Chinese trial scale through niche domain expertise, specialized therapeutic focus, and process automation