Category Archives: Uncategorized

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

Posted in Uncategorized | Leave a comment

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

Posted in Uncategorized | Leave a comment

Vacancy: Head of Trial Master File (INC Research)

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

Posted in Uncategorized | Leave a comment

Thoughts from the DIA EU Electronic Document Management Conference

[Also posted on LinkedIn Pulse] I have just attended the 15th Drug Information Association (DIA) European Electronic Document Management conference in Berlin. Here are a few thoughts and observations that came to mind as I sat through some of the … Continue reading

Posted in Uncategorized | Tagged , , , , | Leave a comment

Fire Destroys Argentine Banking System Archives, Killing 9

Originally posted on mediachecker:
February 6, 2014 While we are sure it is a very sad coincidence, on the day when Argentina decrees limits on the FX positions banks can hold and the Argentine Central Bank’s reserves accounting is questioned…

Posted in Uncategorized | Leave a comment

Proposed EU Clinical Trial Regulation – Update

Well, my optimism from our meeting with one of the UK MEPs a short while ago was misplaced! It appeared a possibility that the intention was to only retain the clinical study report indefinitely and not the whole of the … Continue reading

Posted in Uncategorized | Leave a comment