Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Get Ready for Electronic Document Management Conference

The Drug Information Association (DIA) have just released their Call for Abstracts for the upcoming Electronic Document Management conference in Leiden, Netherlands in May 2016, as follows: DIA invites you to submit abstracts for this upcoming conference in Leiden, only … Continue reading

Posted in Records management practice, Training | Leave a comment

MHRA Comments on Records Retention

It seems that the latest submission from the MHRA on their GCP Forum has provoked a great amount of discussion and raised concerns amongst industry. What is it all about? Well the MHRA have provided some clarification on the topic … Continue reading

Posted in e-records, Records management practice, Regulations, TMF | 1 Comment

US Safe Harbor Scheme Ruled Invalid

The Court of Justice of the European Union today ruled that the European Commission’s decision that the US Safe Harbour scheme provides an adequate level of protection is invalid. Their ruling states: “In the light of the revelations made in … Continue reading

Posted in Data protection, Uncategorized | Leave a comment

Job vacancy: Clinical/Regulatory Records Manager (Actelion)

The Clinical and Regulatory Records Manager will work within the Global Drug Regulatory Affairs department, managing the paper records for Global Clinical Development with an emphasis on adherence to Good Clinical Practice (GCP). The person will: Manage the inactive paper … Continue reading

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ICH Releases Draft GCP Addendum for Consultation

An integrated addendum to ICH E6(R1) Guideline for Good Clinical Practice has been released for public consultation (see LINK  for download). The addendum includes a small number of minor clarifications in section 8 of the guideline but no substantial changes specifically … Continue reading

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Is the Clinical Database part of the Trial Master File (TMF)?

This was a question posed recently on the MHRA GCP Forum (see http://forums.mhra.gov.uk/showthread.php?1858-Database-and-TMF).  I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” … Continue reading

Posted in Compliance, e-records, Technology, TMF | 2 Comments

Vacancy: Ass. Director – TMF (Biogen Idec)

  This position is responsible for managing overall Trial Master File (TMF) operations including third party vendors and TMF systems. Act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, … Continue reading

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