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.
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.
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
Clinical Trials
Advice and guidance to support the provision of pharmacy clinical trials services.
Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites
16 September 2022A 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
Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries
15 November 2022Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs