Delivering advanced therapies requires complex organisational change and close working with product and supply chain companies, regulators as well as patients and carers.
The toolkit provides resources to facilitate the delivery of advanced therapies and enable evaluation of an organisation’s readiness. It offers templates and exemplar documents that will prepare healthcare organisations for the development of local structures, systems, pathways, procedures, processes and workflows. We actively encourage the materials to be tailored to meet the needs of local governance, assurance structures and current ways of working.
The resources have been developed by the ATTC network as part of a project in which they are working with NHS organisations in England, Scotland and Wales and advanced therapy companies to optimise the clinical and commercial pathways for the delivery of cell and gene therapies.
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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. Also see: Business and financial planning, Operational deliveryFind out more
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.Find out more
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.Find out more
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.Find out more
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.Find out more
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.Find out more
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.Find out more