Advanced therapy medicinal products

Topics: Advanced therapy medicinal products

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

Advice and guidance

Pharmacy Institutional Readiness for Exagamglogene Autotemcel (Casgevy®)

This document highlights key areas where Chief Pharmacists should focus pharmaceutical expertise prior to implementation of Exagamglogene Autotemcel.

How to perform preparation risk assessments for ATMPs

Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo Gene Therapies.

Outsourcing ATIMP Handling: A Template Technical Agreement

A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites

Requirements for Governance and Preparation of Gene Therapy

Practical advice for centres implementing Gene Therapies detailing Governance requirements and optimal preparation location decision making support.

Horizon scanning for ATMPs

Describes what horizon scanning is, how it is performed for the NHS and it's importance for ATMPs.

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.

Accessing the CAR-T training passport for clinical pharmacists

The Pan UK Pharmacy Working Group for ATMPs has collaborated with UK BMT (Bone Marrow Transplant) pharmacists to produce a CAR-T verification passport

Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries

Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs

Diagnosis and Medical Management of Acute CAR-T Cell Toxicities in Adults

Consensus guidance (involving Wave 1 and 2 CAR-T centres) on the management of acute CAR-T cell toxicities.

Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites

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

SPS - Specialist Pharmacy Service

NHS

Advanced therapy medicinal products

Advice and guidance