Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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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Booking Now Open for SAG Conference (April 2016)

Just a quick note to mention that bookings are now being taken for the next Conference of the Scientific Archivists Group (SAG). This will be of interest to anyone who is involved in the management and/or archiving of scientific records, … Continue reading

Posted in Records management practice, Training

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

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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

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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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