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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
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
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
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
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
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
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