Local governance

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ATMP Governance Structure

Governance structure organogram for supporting the introduction of ATMPs at the Christie Hospital
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Clinical trials toolbox

A summary of activities across NA-ATTC hospitals geared towards patient centred, safe and efficient trial set-up, delivery and completion
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Ex Vivo (cell based) gene therapy medicinal products – pharmacy institutional readiness guidance

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)
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Example risk assessment for proposed activities involving; Gene Therapy Medicinal Products (GTMPs) or Gene Therapy Investigational Medicinal Products (GTIMPs)

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee
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Exemplar Terms of Reference ATMP Education and Training Committee

Exemplar terms of reference for an ATMP Education and Training Committee at The Christie NHS Foundation Trust
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Gene Therapy Medicinal Products – Governance and Preparation Requirements

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.
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GMO contained use authorisation procedures for clinical trial products in the UK

This guidance summarises the authorisation process for Genetically Modified Organisms (GMO) as Investigational Medicinal Products (IMP) for contained use (CU) within the United Kingdom (UK). These submissions are unique to GMOs, in addition to Clinical Trial Authorisation (CTA) and Ethics
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Governance and operational considerations for delivering ATMPs in hospitals – Webinar

This training webinar gives an overview of the preparations required prior to treating patients with ATMPs
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Research and Innovation Board Terms of Reference – The Christie

Terms of Refence for the Research and Innovation ATIMP Board (a sub-committee of the ATMP board) at The Christie Hospital Manchester. Included are aspects such as the boards powers and membership.