Advice, guidance and individual details for specific advanced therapy medicinal products.
Ex-Vivo (cell based) GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing Ex-Vivo genetically modified organism (GMO) Gene Therapy.
A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the Pharmacy department
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