Industry Toolkit

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pdf
27/02/2023

ABPI Roadmap

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring.
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pdf
01/06/2020

Apheresis process flow

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis.
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pdf
02/02/2022

ATiMP Clinical Trials Quality Technical Agreement Guidance

A guidance document providing an oversight of the purposes and contents of a Quality Technical Agreement (QTA) for use between advanced therapy clinical trial Sponsor and Participating Organisation. The document set outs a proposed standardised format for advanced therapy clinical trial QTA with example roles and responsibilities.
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xlsx
27/02/2023

ATIMP Feasibility Questionnaire FAQ Database Template

A template produced by The Christie NHS Trust to hold and update frequently asked questions and responses to cell therapy trial feasibility questionnaires.
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pdf
03/03/2022

British Pharmacopeia MHRA White paper detailing the Flow Cytometry framework for ‘Good Practice’

A British Pharmacopeia whitepaper for the application of flow cytometry for the cell and gene therapy community.
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Online Article
26/01/2021

Cell and Gene Therapy Insights Paper on Best Practice in Flow Cytometry

This paper highlights the major themes found in designing and applying flow cytometric analysis for cellular therapies and discusses practical solutions to common problems.
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docx
31/01/2024

Cell Therapy/ATMP Clinical Trial Referral form (Sarcoma)

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Online Article
27/02/2023

Clinical trials for medicines: apply for authorisation in the UK

Government advice on how to apply for a clinical trial including eligibility phases model IMPDs costs and how to make changes to your application.
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pdf
01/06/2020

Cytokine release syndrome assessment for CAR-T therapy – Newcastle Hospitals

A tool to assess for and grade cytokine release syndrome in a CAR T therapy patient.
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Online Article
04/12/2020

Diagnosis and medical management of acute CAR-T cell toxicities in adults

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.
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Online Article
27/02/2023

EMA – Clinical Trials Regulation

Information provided by the European Medicines Agency (EMA) on the European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022.
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Online Article
31/03/2021

EMA Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products

The guideline describes specific aspects of pharmacovigilance risk management planning safety and efficacy follow-up of authorised ATMPs as well as some aspects of clinical follow-up of patients treated with such products.
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Online Article
31/03/2021

European Medicines Agency ATMP overview

Main pages from the EMA website focussed on ATMPs.
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pdf
04/09/2023

Evaluation of the Gene Therapy Patient Referral Pathways in the UK

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Online Article
21/07/2020

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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Explore all toolkit sections

  • Governance

    Governance

    Read more about this section.

    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

    Read more about this section.

    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

    Read more about this section.

    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

    Read more about this section.

    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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