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Compassionate use supplies in Europe are unlicensed medicines and not traditional clinical trial supply. As such the quality and distribution considerations are different for compassionate use supplies in Europe. This recording will look at the following aspects of EU Compassionate Use programs:
- QP requirements & expectations
- Importing compassionate use medicines into the EU
- Relabeling of compassionate use material
- The role of the healthcare physician
- Bona Fide e-checks
- Compassionate use supply distribution