Losing GSi – MHRA emails are changing
...addresses ending in nibsc.org will remain the same. Don’t miss the next post, sign up to be notified by email when a new post is published on the Inspectorate blog....
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Supply Chain webinar: recording now available
Posted by:
Emanuela Krasteva, Posted on:
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Categories:
Compliance matters, Events and symposia, Good distribution practice
...you who could not make it, the recording of the webinar is available to view on our MHRAgovuk YouTube channel. You can also view our previous related blog post, which...
Process Licensing Office joins the Inspectorate
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group. The Process Licensing Office are responsible for: Processing Initial and Variation Applications for...
PIC/S meeting - February 2017
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland The press release for the meetings has been recently published. The...
ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
Posted by:
Andrew Fisher and Jason Wakelin-Smith, Posted on:
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Categories:
Good clinical practice, Uncategorized
The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1,...
Potential supply issues
The last couple of months have seen some catastrophic weather conditions across the globe. These can have a significant impact upon the pharmaceutical supply chain. We have already received reports...
MHRA Guidance on Coronavirus
...the situation develops. Don’t forget that MHRA is also here to support you, and if you have any questions then do contact the Clinical Trials Unit Helpline (clintrialhelpline@mhra.gov.uk or 020...
Pharmacovigilance Inspection Metrics April 2018 to March 2019
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019. The full metrics report is available on GOV.UK. We hope that...
Pharmacovigilance Inspection Metrics April 2017 to March 2018
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018. The full metrics report is available on GOV.UK. We hope that...
Pharmacovigilance inspection metrics April 2019 to March 2020
Posted by:
Sarah Gomersal, Posted on:
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Categories:
Compliance matters, Good pharmacovigilance practice
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020. The full metrics report is available on GOV.UK. We hope that...
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