In-Vivo (virus based) Gene Therapy Medicinal Products – Pharmacy Institutional Readiness Guidance

In-vivo Gene Therapies are ATMPs which are handled and manipulated by Pharmacies.

The purpose of this document is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in-vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.

This document presents a flow diagram outlining a stepwise approach to implementing in-vivo (virus based) GTMP. It is followed by checklists which relate to the various steps presented in the diagram.