Education and training resources

Education and training resources

To safely deliver advanced therapies, staff across manufacturing, supply chain, and clinical support functions need specialised training. This section includes resources for learning about ATMPs, including e-learning modules, competency assessments, and materials to support both internal teams and external stakeholders.

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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
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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Online Article
01/10/2019

Horizon scanning for ATMPs

Horizon Scanning is the systematic process of identifying new medicines or technologies in development. This information is useful to clinical trials sponsors ATMP developers and manufacturers organisations aspiring to hold ATMP marketing authorisations as well as to NHS group members and beyond.
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Online Article
28/11/2022

ISBT 128 labels for advanced therapies – eLearning Module

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.
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pdf
17/05/2021

Non-cellular GMO therapies: a visual guide

A visual guide to the preparation administration and disposal of non-cellular genetically modified organisms (GMOs) in a clinical setting.
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Online Article
08/12/2020

Patient and public perspectives on cell and gene therapies: a systematic review

This review highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies. Patient and public perceptions of these therapies alongside evidence of clinical and cost-effectiveness will be central to their uptake and use.
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pptx
01/06/2020

Thawing and visual inspection of cell therapy medicinal products

A training resource on the importance of correctly thawing and inspecting cell therapy medicinal products.
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mp4
01/09/2020

Visual inspection of cell therapy medicinal products

A training video demonstrating the visual inspection of a cell therapy product prior to infusion.
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  • Governance

    Governance

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    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

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    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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