Blogging matters
...Government, to discuss how blogging can be put it its best use and in the Inspectorates' case to benefit you, our stakeholders. Play your part So that we make sure...
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Exports and customs procedures
Posted by:
Cheryl Blake, Posted on:
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Categories:
Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice
...been stored, handled and shipped in accordance with GDP. Your freight forwarder or shipping agent is a key partner It is best practice to routinely provide the freight forwarder, shipping...
Risk Adaption in Clinical Trials of Investigational Medicinal Products (CTIMPs)
...and the reliability of safety information - e.g. not submitting all SAE reports immediately to the Sponsor; IMP management with respect to traceability and accountability - e.g. applying normal prescribing...
GMDP Symposium 2017- GMP Days
Posted by:
grahamcarroll, Posted on:
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Categories:
Compliance matters, Events and symposia, Good manufacturing practice
...the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK. While negotiations continue the UK remains a full and active...
Out of Specification Guidance
Posted by:
Lesley Graham, Posted on:
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Categories:
Compliance matters, Good laboratory practice, Good manufacturing practice
...how best it could be used. The guidance offers a stepwise approach on what should be considered at the each stage of the investigation. It has recently been reviewed and...
MHRA Laboratories Symposium 2019 ... plus GXP mailbox update
Posted by:
Martin Reed, Posted on:
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Categories:
Events and symposia, Good clinical practice, Good laboratory practice, Good manufacturing practice
...inspection Quality Assurance and Quality Control - the difference between the two, how they can support each other, with examples from inspections In the afternoon, after a hearty lunch, we...
How to manage temporary GDP process changes and risks through the COVID-19 pandemic
...this as early as practicable so we can assist in addressing your issues so that patients continue to receive the best possible care. We can be contacted at GDP.Inspectorate@mhra.gov.uk ....
ePRO – An Inspector’s Perspective
...agree to the data changes being made months after the event actually occurred, in some cases to facilitate a ‘best-fit’ of IMP administration vs. the planned administration schedule. It was...
Round Table: The impact of Electronic Health Records on UK Clinical Trials
Posted by:
Paula Walker, Gail Francis and Jennifer Martin, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
...in more detail about the requirements of electronic health records under the clinical trials legislation, and how we can best work together to meet those requirements within systems already implemented...
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
...trial. This is a diverse and complex area which is continuously developing and expanding, resulting in issues with source data leading to data integrity concerns. Andy’s presentation outlined how best...
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