Understanding The Essential Role Of Qualified Persons In Clinical Trials

Few roles in clinical supply carry the level of personal accountability held by the Qualified Person (QP). In the EU and UK, a QP’s certification decision cannot be overruled by management, and legal liability can attach to the individual, creating a sharp contrast with the US regulatory model.

This article explores what that responsibility means for investigational medicinal products (IMPs), including the declaration required when an IMP is manufactured outside the EU or UK. It also examines the three categories of documentation reviewed before a batch can be certified, alongside the training and audit expectations that apply to QPs. Beyond the certification process, the article considers how the UK’s withdrawal from the EU in 2020 changed the validity of certifications between the two markets and the implications for clinical supply operations. Finally, it explores the factors that contribute to an effective partnership between sponsors and QPs.

Read the full article to understand how these responsibilities, requirements, and working relationships fit together.