Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

MHRA Comments on Records Retention

Posted on December 2, 2015

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

Posted on October 6, 2015

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)

Posted on August 12, 2015

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

Posted on July 31, 2015

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 →

Posted in Regulations, TMF | Leave a comment

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

Posted on July 27, 2015

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)

Posted on July 23, 2015

  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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Vacancy: Head of Trial Master File (INC Research)

Posted on July 2, 2015

Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical … Continue reading →

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