Clinical trials
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Supply of aseptically prepared IMPs across legal boundaries
19 November 2025The legal and practical implications when transferring aseptically prepared Investigational Medicinal Products (IMPs) across legal boundaries.
Ex-Vivo Non-GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
5 November 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing Ex-Vivo Non-Genetically Modified Organism Gene Therapies.
In-Vivo Non-GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
30 October 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing In-Vivo Non-Genetically Modified Organism Gene Therapies.
Somatic Cell Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
25 March 2025This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Somatic Cell Therapy Product.
In-Vivo GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing In-Vivo Genetically Modified Organism (GMO) Gene Therapy.
Ex-Vivo (cell based) GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance
20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing Ex-Vivo genetically modified organism (GMO) Gene Therapy.
How to undertake an audit of a cell therapy laboratory
18 February 2025A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the Pharmacy department
The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
21 November 2024Identifying key areas where pharmaceutical expertise is required by sponsors for conducting non-commercial clinical trials
Supporting funding applications for CTIMPs
21 November 2024Sponsor pharmacy role in funding applications and establishing costs for sponsor activities
Outsourcing ATIMP Handling: A Template Technical Agreement
7 February 2024A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites