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A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

Posted by: , Posted on: - Categories: GDP, Good distribution practice, Wholesale Dealer’s Licence

The aviation and marine sector are a journey away from the traditional scope of a Wholesale Dealer’s Licence (WDA (H)), and one of unique and specific challenges. The lorries and trucks that supply medicines to hospitals and pharmacies also head …

MHRA Good Clinical and Laboratory Practice Symposia (11 and 12 February 2025)

Posted by: and , Posted on: - Categories: Events and symposia, Good clinical practice, Public involvement

Come and join the next MHRA Symposia in February 2025 and hear the latest on Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) in the UK from MHRA inspectors and regulators. Registration is available on the dedicated symposia website for in-person …

Public Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2

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As a GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to inform you that Annex 2 of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline has …

DSUR Submissions and Fees are Changing from 1 June 2024

Posted by: and , Posted on: - Categories: Clinical Trials

February 2025: We have updated some details in this blog post to reflect changes to the payment system and annual progress reports (APRs). The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the …

Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium

Posted by: , Posted on: - Categories: Good pharmacovigilance practice, Inside the Inspectorate

The world of GPvP is highly regulated, but the 2024 GPvP symposium showcased how regulation, collaboration and innovation can work together to enhance compliance, provide opportunities for better ways of working, and improve patient lives. The Symposium welcomed over five …