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

Bringing together NHS experts and regulators covering topics of quality assurance, quality control, good manufacturing practice and regulatory expectations.
Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo Gene Therapies.
A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites
Practical advice for centres implementing Gene Therapies detailing Governance requirements and optimal preparation location decision making support.
Describes what horizon scanning is, how it is performed for the NHS and it's importance for ATMPs.
Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.
The Pan UK Pharmacy Working Group for ATMPs has collaborated with UK BMT (Bone Marrow Transplant) pharmacists to produce a CAR-T verification 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