EU Compassionate Use Programs – Where’s My Drug

By its nature, EU compassionate use supply is needed urgently. This means packaging, labeling, and distribution must be executed rapidly and efficiently. Trial sponsors must know what issues to manage and need to select the transportation routes carefully, especially during COVID-19. Distributing compassionate use material within Europe has not been historically challenging, but the COVID-19 pandemic has created logistical obstacles including a decrease in transportation options and closed borders.

In our previous Water Cooler Chat article, we introduced EU Compassionate Use clinical programs, and in this article, our experts – Gavin Morgan, Senior Manager of Global Logistics, Uday Pathapati, Senior Manager of Clinical Project Management and Tiago Mateus, Project Manager from Marken – describe the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges. This article will discuss:

  • How to effectively set up your distribution – what key items are required prior to initiating the shipment request
  • Considerations when preparing the shipment for dispatch – patient confidentiality, contactless delivery, temperature management and temp excursion handling
  • Specialist courier interactions
  • COVID-19 solutions and considerations