Logistics

Logistics

Resources in this category include information around shipping and ordering, chain of custody, receipt and storage, dispensing, preparation, administration, returns and disposal.

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ABPI Roadmap

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring.
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NIHR Clinical Trial Routemap

The NIHR Clinical Trial Routemap is an interactive colour-coded tool to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices along with more detailed information available at ‘stations’ along the route.
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Pharmacy institutional readiness for marketed CAR-T therapy: checklists for pharmacy services

A Pharmacy Working Group of ATMPs resource. CAR-T treatments require governance and management by Chief Pharmacists. They present risks which Chief Pharmacists should ensure are minimised. Whilst collaboration with expert cellular product handling colleagues will be key operationally it may present challenges for Pharmacy to embed this new working relationship.
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Recommendations on the procurement of starting materials by apheresis for ATMP manufacture

This guidance document presents a consensus view on standardised approaches to mononuclear cell procurement to reduce unnecessary complexity and variation.