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.
