Toolkits

This Toolkit is a compendium of documents detailing best practice and expert guidelines in relation to the manufacture of Advanced Therapy Medicinal Products (ATMPs). Its purpose is to disseminate learnings from the ATTCs and increase awareness of good manufacturing practice for ATMPs.
Guidance has been categorised into three areas; Cell Analysis, Cell Manufacture, and Pharmacy and Regulatory.

The NHS readiness toolkit provides resources for healthcare organisations that are working towards the delivery of advanced therapies for patients. It is intended for professionals across key specialisms involved in the delivery of advanced therapies.

The Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) has developed a tool which collates the various regulatory guidance documents and processes encountered along your pathway to an active ATMP clinical trial. The tool aims to highlight efficiencies that may support progress towards making  the UK government’s goal of 150 days from clinical trial submission to first patient applicable to ATMPs.
A glossary of the review bodies involved in trial site start‑up across the United Kingdom is provided, and the scope and underlying assumptions are defined. An interactive pathway then cross‑links to relevant cheat sheets aligned to each process step. Information has been reviewed by the relevant regulatory bodies.