WS25.1 – Bridging Regulations: Managing Compliance Across Borders in Clinical Supply Logistics

As clinical programs expand into increasingly diverse geographies, the “border” is no longer just a physical line on a map—it is a complex, shifting landscape of regulatory friction. By 2026, the global clinical supply chain must harmonize the stringent requirements of the EU Clinical Trials Regulation (CTR) with emerging frameworks in the APAC region, post-Brexit UK variations, and the evolving oversight of LATAM authorities. This hands-on workshop provides a masterclass in navigating the regulatory “checkpoints” that can make or break a global trial’s timeline. Moving beyond static checklists, this session utilizes live simulation exercises to address real-world compliance crises. We will dive into the nuances of Annex 16 certification in a decentralized world, the complexities of “Qualified Person” (QP) oversight for cross-border shipments, and the data integrity requirements of the ICH-GCP E6 (R3) updates. Participants will work in peer groups to map out a global distribution strategy that balances speed with “bulletproof” compliance, specifically focusing on the intersection of customs “red tape,” fiscal representation, and local labeling mandates.