L02.2 – Sourcing of commercial products from Ex-EEA countries

As clinical trials become increasingly global, sponsors often source comparator and standard-of-care products from third countries to address cost, availability, and supply constraints. This session will examine the regulatory, quality, and logistical challenges involved, including ensuring product authenticity, navigating import/export requirements, and maintaining GDP/GMP compliance. Experts will share practical strategies and case examples for managing risk and ensuring reliable supply across complex international clinical trial networks.