Module 5 Presentations

18/07/2024

The Qualified Person (QP)

The Organisation for Professionals in Regulatory Affairs

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The role of the QP

• The concept of the Qualified Person is a unique regulatory requirement that applies only within the EU. • Each holder of an authorisation to Manufacture products for use in a clinical trial, within member states of the EU, must name a person eligible to act in the capacity of QP. • The primary legal responsibility of the QP is to certify batches of medicinal products prior to use in a clinical trial or prior to release for sale and placing on the market.

The Organisation for Professionals in Regulatory Affairs

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