Preparation of Advanced Therapy Medicinal Products

A. Black (Newcastle, UK)

Pharmacists play an important role in the safe implementation of ATMPs. Wherever possible we advocate that medicines are issued to the clinical area in a ready to administer presentation. Some ATMPs arrive ready to administer but some require a preparation step to make them ready to administer to patients. This presentation will discuss the optimal location in which any preparation should be undertaken. It will discuss that this may vary depending on the type of ATMP, and will ask whether pharmacy training is currently sufficient to safely handle cell or tissue based products. Where preparation occurs in areas other than pharmacy aseptic suites it will discuss the oversight role of pharmacist who ensures, from a governance perspective, that the medicine is being handled in line with the Summary of Medicinal Product Characteristics or the Clinical Trial Protocol. The Pan UK Pharmacy Working Group for ATMPs has produced pharmacy institutional readiness guidance for ATMPs which will be referenced throughout the presentation.

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