Clinical trials
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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
Pharmacy manual checklist for clinical trials for ATIMPs
2 March 2023Pharmacy manual content expectations for optimal site implementation of ATIMP clinical trials.
Closing clinical trials
12 December 2022Sponsor pharmacy responsibilities during trial closure and the final monitoring visit
Monitoring and auditing clinical trials by participating sites
12 December 2022An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing a clinical trial as part of participating site management
Constructing a pharmacy manual for clinical trials
12 December 2022Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials
Feasibility and setting up of clinical trials at participating sites
12 December 2022An overview of the Sponsor Pharmacy's responsibilities during setup of a clinical trial as part of participating site management