Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

MHRA Draft Guidance on GxP Data Integrity…..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

Posted in Regulations, TMF | 1 Comment

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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Case study-led agenda develops for TMF Europe

If you work with Trial Master Files, you might be interested to hear about IQPC’s TMF Europe conference. Now in its second year, this is highly interactive and case study driven. The agenda does away with your usual mix of classroom-style … Continue reading

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Training Course: Managing Electronic Records

This is a just a quick promo for a one-day training course that I am running with my colleague, Russell Joyce, on behalf of the Scientific Archivists Group. The course is aimed at anyone with responsibility for electronic records….. for … Continue reading

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Wingspan eTMF

We are pleased to announce the addition of Wingspan eTMF to our list of featured advertisers. Wingspan – founded in 1996 by CEO Troy Deck – has been in the electronic document management business for many years, with its suite … Continue reading

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