How gene therapies are changing the Qualified Person role in the EU

Sharp Clinical’s Mike Jentsch explains how the rise of gene therapies is reshaping QPs' approach to risk assessment and regulatory oversight. As products grow more complex and regulation races to catch up, QPs are continuously stress‑testing each stage – from starting material to the final syringe – to balance innovation with uncompromising patient safety. Sharp Clinical’s Mike Jentsch explains how this is reshaping their approach to risk assessment and regulatory oversight. For organisations outside Europe, the role of the Qualified Person (QP) is often unfamiliar. In the EU and UK, however, a QP is legally required to certify every batch…

Source: Clinical Trials Arena