Module 5 Presentations

18/07/2024

Returns & Destruction

• Agree process for reconciliation and destruction of surplus and unused supplies at study commencement • Agree division of responsibility between investigator site and clinical supply group • Reconcile and destroy supplies as soon as possible by appropriate process (high – temperature incineration) • Certificates of Destruction should give detail of materials destroyed

The Organisation for Professionals in Regulatory Affairs

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Summary

In this presentation we have covered...

• The role of the Qualified Person • The role of the IMP QP • History of Legislation • Manufacturing and importation requirements • Regulatory framework under which clinical trials are managed • Issues related to manufacture, packaging and distribution of clinical supplies

The Organisation for Professionals in Regulatory Affairs

30

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