The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights …
We have recently had a number of situation where importers of unlicensed medicines have attempted to notify MHRA of centrally authorised products for import as unlicensed medicines. This is not appropriate, as these are not unlicensed medicines and should be distributed …
...may also require periodic checks, such as equipment performance. Specifying exact time intervals (eg ‘every 60 minutes’) may result in an incentive for staff to ‘back date’ the time of...
A highlight of our work is when we get to engage with you through our symposia. It is a rewarding opportunity for us to keep many hundreds of you – our stakeholders - up to date with the latest regulatory …
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