Advice, guidance and individual details for specific advanced therapy medicinal products

Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.
Members of the Pan UK Pharmacy Working Group for ATMPs have collaborated with UK BMT (Bone Marrow Transplant) pharmacists to produce a CAR-T training passport
Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs
Consensus guidance (involving Wave 1 and 2 CAR-T centres) on the management of acute CAR-T cell toxicities.
A summary of the implications of the UKs exit from the EU for clinical trial sites for both IMP and ATIMPs, including supply to and from Northern Ireland
A template Quality Technical Agreement for Outsourcing the Receipt, Storage, Preparation and Onward Supply of Marketed Cryopreserved ATMPs.
CAR-T Therapy requires some medicines to be restricted, this guidance provides details and recommended wash-out periods for restricted medicines.
Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.
This document provides expert clinical pharmacy guidance on supportive medicines in order to facilitate the treatment of complex CAR-T Cell Therapy patients.
This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.