MHRA and US FDA tackle challenging data integrity
MHRA and US FDA tackle challenging data integrity
Following the February 2020 MHRA and FDA GCP symposium in London, our second joint paper is now available.
Get involved and tell us your pharmacovigilance hot topics
Posted by:
Sophie Radicke, Posted on:
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Categories:
Compliance matters, Events and symposia, Good pharmacovigilance practice
Take part in our survey and let us know what you would like to hear about at the next GPvP symposium.
Transfer of analytical methods
Posted by:
Chris Smith, Posted on:
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Categories:
Compliance matters, Good laboratory practice, Good manufacturing practice
Guidance for manufacturers and contract testing laboratories on the process of transferring a method for outsourcing of testing
Too good to be true? How to play your part in protecting the UK medicines supply chain (updated)
Posted by:
Emanuela Krasteva, Posted on:
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Categories:
Compliance matters, Events and symposia, Good distribution practice
The MHRA is inviting you to attend a free webinar as part of its commitment to providing guidance to industry and supporting stakeholders to prevent falsified medicines entering the legal supply chain.
Is your eSystem actually an eCRF (electronic case report form)?
With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision
Posted by:
Gail Francis, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
The ICH Management Committee is taking a unique step to provide a status update on the revisions to this guideline, via a public virtual conference on 18 and 19 May 2021. Register now.
Inspectors grounded - a year of innovation
Posted by:
Paula Walker, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health
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.
Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021
Posted by:
Kiernan Trevett, Posted on:
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Categories:
Compliance matters, Good pharmacovigilance practice
All the sources of guidance published by the MHRA so far, plus further information if you still have questions.
Reference Safety Information (RSI) for Clinical Trials- Part III
Posted by:
Mandy Budwal-Jagait, Gail Francis and Dr Maria Beatrice Panico, Posted on:
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Categories:
Compliance matters, Good clinical practice
Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
Pharmacovigilance requirements for UK authorised products - 13 January 2021
Posted by:
Anna Adams, Posted on:
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Categories:
Compliance matters, Events and symposia, Good pharmacovigilance practice, Wider MHRA
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.
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