21 July 2020 · This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing In-Vivo (virus based) Gene Therapy.
24 February 2020 · This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on Governance in the event of an OOS ATMPs being offered for use.
27 September 2019 · Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.
2 October 2018 · This document outlines key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing CAR-T Therapy.