Electronic health records
...tools in clinical trials” published on 12 August 2010 look for any eclinical advice and tools online - we cannot recommend any particular product or assessment as this will vary...
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Launch of the MHRA Blood Forum
Posted by:
Stephen Grayson, Posted on:
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Categories:
Compliance matters, Good manufacturing practice
...you will see online. It helps those participating to identify who they are talking to and build professional relationships. Welcome to the MHRA Blood Forum and happy posting. Medical test-tube...
Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned
Posted by:
Gail Francis, Martin O'Kane, Kirsty Wydenbach and Lisa Campbell, Posted on:
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Categories:
Good clinical practice, Inside the Inspectorate
...in 2014 with further guidance and examples of remote monitoring. In 2020]}** this risk-adapted approach also featured in our guidance around COVID-19 flexibilities, and organisations have been asking if we...
MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use
...pharmaceutical industry. For an overview of unlicensed Cannabis-Based Products for Medicinal use (unlicensed CBPMs), please see the following guidance which was updated in March 2020]}**: “The supply, manufacture, importation and...
Who inspects the Inspectors? (Part II)
Posted by:
Ian Jackson, 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, Wider MHRA
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part...
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
https://youtu.be/AGTitnGny50 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....
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
...in member states. In the UK this is currently the SI 2004/1031 (as amended). It is important to note that although the transition period ended on 31 December 2020]}**, the...
MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'
...London in February 2020]}**, covering international collaboration, sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs. MHRA hope to publish a further paper jointly...
MHRA Good Practice (GxP) inspections during the COVID19 outbreak
Posted by:
David Churchward, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
...regulatory inspection programmes necessary to protect public health. On 20th March 2020]}** MHRA announced a risk-based prioritisation of Good Practice inspections due to the COVID19 outbreak. Until further notice, MHRA...
MHRA GCP Non-Commercial Symposium 2019
Posted by:
Jennifer Martin, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
...miss the next joint MHRA/FDA GCP symposium with a commercial focus on 13 and 14 February 2020]}**. Registration details can be found here. Don’t miss the next post, sign...
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