Pharmacy and Regulatory

Pharmacy and Regulatory

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Best Practice re: Transfer of Disinfection in Pharmacy

A guidance document detailing the minimum requirements to achieve best practice for Transfer Disinfection in a Pharmacy
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Gene Therapy Medicinal Products – Governance and Preparation Requirements

A guidance document providing practical advice for centres implementing Gene Therapies detailing Genetic Modification Safety Committees (GMSC), Governance requirements and optimal preparation location
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Guidance on Pharmacy oversight and Pharmacist Supervision of licensed ATMPs requiring a preparation/reconstitution step

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs, providing definitions of oversight and supervision and clarifies where each are required when implementing Advanced Therapy Medicinal Products
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Q&A document about the role of a QP within Advanced Therapies

An FAQ document describing the regulatory and Qualified Person requirements for the ATMP Product Journey
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Report on the Current Guidelines Regarding Advanced Cell Therapy Safety, Efficacy and Potency Testing

An evaluation of current guidelines and current technologies used to assess the safety, efficacy and potency of Advanced Therapies