Education and training

Education and training

Education and training

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Online Article
27/01/2022

Advanced therapy investigational medicinal product (ATIMP) clinical trials – eLearning Module

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user a refresher of standard clinical trial studies and explains the additional features which impact on the design of trials for investigational advanced therapy medicinal products (ATIMPs) and how they can be addressed. Roles and responsibilities, governance and sources of support for ATIMP clinical trials are also outlined.
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pdf
27/02/2023

Apheresis Training and Competency Manual

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.
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pdf
22/09/2022

ATMP Pharmacy Gene Therapy Presentation

A presentation on ATMP Pharmacy Gene Therapy treatments.
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Online Article
18/05/2021

ATMPs in paediatric haematology – Webinar

A look at some of the recent impacts of ATMP treatments on children at the Royal Manchester Children's Hospital
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Online Article
22/03/2021

ATMPs on the horizon – Webinar

Focussing on four upcoming ATMPs in 2021, how they work, how patients might benefit, how they are given and other practical issues staff need to aware of.
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pdf
27/09/2022

ATMPs Pharmacy Training Session

PowerPoint presentation for an educational seminar on ATMP pharmacy.
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Online Article
30/09/2020

Basics of Gene Therapy – Webinar

This is a training webinar that covers the basics and introduction of in vivo gene therapy
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Online Article
01/10/2020

Cell therapy basics – Webinar

This training webinar gives an overview of basics of cell therapy and some applications
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pdf
18/10/2021

Competency Assessment: Safe use of dry shippers and/or dry ice

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.
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pdf
18/10/2021

Competency Assessment: Thawing cryopreserved cell-based therapeutic products

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely while thawing.
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pdf
27/02/2023

Developing an NIHR CRF for safe delivery of Oncology ATMP trials

Poster outlining the approach to developing an NIHR Clinical Research Facility which is safe for the delivery of Oncology ATMP trials.
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Online Article
01/10/2020

Dosing considerations for ATMPs – Webinar

A webinar to give an introduction into the considerations for dosing patients with ATMPs
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Online Article
01/10/2020

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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Online Article
20/10/2020

Institutional readiness: governance and operational considerations for delivering ATMPs in hospitals – webinar

A webinar giving an overview of governance, operational and clinical challenges which need to be overcome in order to implement these novel medicines
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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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  • Advanced therapy clinical trials process overview

    Advanced therapy clinical trials process overview

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    This section features The NIHR Clinical Trials Toolkit and The ABPI ATMP road map

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  • Trial Governance

    Trial Governance

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    Information regarding the governance arrangements required within the NHS to approve, set up and manage clinical trials of advanced therapy investigational products is included here, with details on local governance, committees, feasibility and risk assessments.

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  • Procurement of Starting Materials

    Procurement of Starting Materials

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    Information and considerations during the collection of starting materials for the manufacture of advanced therapies can be found here, including model SOPs in relation to:

    • Solid tumours A suite of SOPS by cancer type relating to sample collection for isolation of tumour-infiltrating lymphocytes (Tils)
    • Blood (aphaeresis) A suite of SOPS for adoptive cellular therapy (Immune Effector Cells)

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  • Receipt, storage & issue of advanced therapies

    Receipt, storage & issue of advanced therapies

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    Available here are examples of checklists and templates for the safe receipt, storage and issue of advanced therapies within the NHS.

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  • Pharmacy considerations

    Pharmacy considerations

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    The considerations for hospital pharmacy departments delivering advanced therapies, including:

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  • Clinical management of patients at site

    Clinical management of patients at site

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    Includes exemplar SOPs and information regarding the clinical management of patients receiving advanced therapies in a hospital setting, covering patient consent, treatment, management of toxicities and follow-up care.

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  • Education and training

    Education and training

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    This section includes links to webinars, e-learning modules and a range of resources, to assist all staff delivering advanced therapy trials in an NHS setting.

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  • Performance management and metrics

    Performance management and metrics

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    An outline of the barriers to effective advanced therapy clinical trial set up, changes to overcome these barriers, and the key metrics to measure success in terms of trial set up and patient referral and recruitment is available here.

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  • National infrastructure, templates and guidance

    National infrastructure, templates and guidance

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    Links to information on the national infrastructure surrounding the clinical trial application process, also further guidance, and templates to assist in the set up and delivery of advanced therapy clinical trials. Including examples of model ATiMP clinical trial agreements.

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    • Explore all toolkit sections

  • 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

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    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

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    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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