This document sets out an example generic checklist for allogeneic, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs).

This document sets out an example generic checklist for autologous, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs)

This document sets out an example generic checklist for receipt and storage of fresh, allogeneic, cellular Advanced Therapy Medicinal Products

This document sets out an example generic checklist for receipt and storage of fresh, autologous, cellular Advanced Therapy Medicinal Products.

Form to complete when receiving, processing and releasing fresh cells for manufacturing

A checklist to confirm ATMP is received appropriately from the manufacturer prior to administration to a patient

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely with dry shippers and/or dry ice.

Advice produced by the Pan UK Pharmacy Working Group for ATMPs for Pharmacy sites on costings for clinical trials of ATMPs, using the NIHR interactive costing tool.

This document produced by the Pan UK Pharmacy Working Group for ATMPs provides guidance on the management of acute CAR-T cell toxicities to help inform the development of local guidelines and to standardise the management of acute CAR-T cell toxicities across the UK. This is a consensus guideline developed with input from the pharmacists and consultants from the first and second wave CAR-T centres.

Form to be completed on the disposal of IMP or ATMP

Ex vivo gene therapy medicinal products are ATMPs, which require pharmacy oversight, even when being handled elsewhere within a healthcare organisation. This document produced by the Pan UK Pharmacy Working Group for ATMPs outlines the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any ex vivo (cell based) Gene Therapy Medicinal Product (GTMP)

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee

Template for the feasibility and risk assessment of all clinical trials (not just ATIMP)

A Pharmacy Working Group for ATMPs resource. Pharmacy is often the first port of call when an organisation wishes to use a gene therapy and needs to provide pragmatic guidance to facilitate the introduction of these innovative products. This document is designed to give practical advice to centres wishing to undertake gene therapy trials and need to understand the requirements and recommendations for governance and, in particular to have in place a Genetic Modification Safety Committee. The document also gives practical advice for centres to help them understand operational requirements including deciding the optimal location for preparation.

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs, providing definitions of oversight and supervision and clarifies where each are required when implementing Advanced Therapy Medicinal Products