We host a weekly virtual Water Cooler Chat series, where our subject matter experts host informal discussions around a number of clinical supply hot topics. This week we are discussing European Compassionate Use Programs
In this Water Cooler Chat whitepaper, our experts – Tris Evans, VP of Global Clinical Quality, Gavin Morgan, Senior Manager of Global Logistics and Uday Pathapati, Senior Manager of Clinical Project Management – discuss what factors need to be considered from a quality, packaging and labeling, logistical and risk management perspectives when planning an EU Compassionate Use Program.
Compassionate use supplies in Europe are unlicensed medicines and not the traditional clinical trial supply. As such the quality and distribution considerations are different for compassionate use supplies in Europe.
This article will provide an overview on:
- QP requirements & expectations
- Importing compassionate use medicines into the UK & EU
- Relabeling of compassionate use material
- The role of the healthcare physician
- Bona Fide checks
- Compassionate use supply distribution
Download our “European Compassionate Use Programs” whitepaper (PDF)
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