Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

MHRA Publishes Latest GCP Inspection Findings

The MHRA today released on their website their annual report of GCP inspection findings. It is interesting to note two critical findings for data integrity issues…. something that industry has been talking much about over recent months. It would be … Continue reading

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What’s in a name?

“A rose by any other name would name would smell as sweet” is a frequently referenced quote from William Shakespeare’s Romeo and Juliet…. meaning that the name is not as important as the object itself. This blog post is a … Continue reading

Posted in Records management practice, Training | Leave a comment

EMA Publishes New TMF Guideline for Consultation

The European Medicines Agency (EMA) has published (12-April-2017) a new guideline “on good clinical practice compliance in relation to trial master files” (TMF). This guideline includes and updates the guidance issued previously in the EMA draft reflection paper on trial … Continue reading

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MHRA Draft Guidance on GxP Data Integrity….. a Few Thoughts

In July 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) released a definitions and guidance document on the topic of data integrity for GxP regulatory data. The public consultation period closed on 31 October 2016. However, I’ve been hearing … Continue reading

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ICH GCP Guidelines (E6) Addendum Now Available

So after securing approval at the November ICH meeting in Osaka, the revised text of the ICH guidelines for Good Clinical Practice – otherwise known as ICH E6(R2) – has been published on the ICH website….. and also available to … Continue reading

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What Impact for the Trial Master File (TMF) of ICH E6(R2)?

So we are now extremely close to Step 4 of the ICH E6 process, resulting in a final, approved revision of the guidelines for good clinical practice…. the first revision since the mid-1990’s. The draft was circulated for review (June … Continue reading

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Update: EMA Reflection Paper on Trial Master Files

A while ago I posted information here regarding the draft reflection paper from the EMA on trial master files (TMF). At that point, the intention was to bring the contents of the reflection paper along with other related guidance into … Continue reading

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