Tag Archives: mhra

Thoughts from the DIA EU Electronic Document Management Conference

[Also posted on LinkedIn Pulse] I have just attended the 15th Drug Information Association (DIA) European Electronic Document Management conference in Berlin. Here are a few thoughts and observations that came to mind as I sat through some of the … Continue reading

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The World Slowly Wakes to the Reality of TMF Requirements

Perhaps my title is somewhat harsh but I perceive more than a little frustration in the announcement today from the MHRA that they are revising their definition of critical inspection findings to include cases “where provision of the Trial Master … Continue reading

Posted in Compliance, Records management practice, Regulations, TMF | Tagged , , , | 2 Comments

MHRA Guidance on Good Clinical Practice

On 24th September 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) published a Good Clinical Practice Guide. Containing 542 pages, this is an essential reference book for anyone involved in some way with the conduct of clinical trials of … Continue reading

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