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

The introduction of advanced therapies into commercial treatment pathways requires significant financial investment in resources, facilities, and technology. Information available here will help organizations develop robust business and financial plans as they prepare to deliver advanced therapies at scale.

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.

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. 

Information is available here to support building understanding of how clinical sites deliver advanced therapies to patients, including details of patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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.

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.

This section has a range of resources – split into 8 sub-sections – to assist industry sponsors and partners in understanding the process for preparing for the delivery of advanced therapy clinical trials. Its objective is to share best practices regarding governance, infrastructure, and processes that underpin successful trial execution.