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Articles, Advanced therapy medicinal products

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Pharmacy Institutional Readiness for Exagamglogene Autotemcel (Casgevy®)

23 August 2024This document highlights key areas where Chief Pharmacists should focus pharmaceutical expertise prior to implementation of Exagamglogene Autotemcel.

How to perform preparation risk assessments for ATMPs

10 April 2024Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo Gene Therapies.

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

Requirements for Governance and Preparation of Gene Therapy

6 February 2024Practical advice for centres implementing Gene Therapies detailing Governance requirements and optimal preparation location decision making support.

Horizon scanning for ATMPs

13 June 2023Describes what horizon scanning is, how it is performed for the NHS and it's importance for ATMPs.

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

2 March 2023Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.

Accessing the CAR-T training passport for clinical pharmacists

28 February 2023The Pan UK Pharmacy Working Group for ATMPs has collaborated with UK BMT (Bone Marrow Transplant) pharmacists to produce a CAR-T verification passport

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

Diagnosis and Medical Management of Acute CAR-T Cell Toxicities in Adults

16 September 2022Consensus guidance (involving Wave 1 and 2 CAR-T centres) on the management of acute CAR-T cell toxicities.

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
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