Tuesday, February 18, 2014

Focus Workshop Labmanual - Slide decks available for download


EBF is happy to inform you that the EBF Lab Manual Workshop was a great success. We succeeded in reaching out to the majority of the stakeholders involved in preparing or using the lab manual for PK samples for clinical volunteer and multi centre (MCT) patient trials.
Our multi-stakeholder document got great input on 5 and 6 Februaru in Brussels. Industry representative from clin ops, clin Pk, central labs, phase I clinics, couriers… and RQA (legacy BARQA) gave support and provided input into the lab manual.

In true EBF style, the meeting was very interactive and there was full support by all – with the desire to use the final document as the point of reference. During the meeting, enhancements to the document were proposed, which we will now integrate in the next and final version of the manual. For this, our current BA team will be supplemented with representatives from above mentioned stakeholders  (Quintiles, Covance, LKF, PRA, QPS, CRS) to make the document a bullet proof template for Phase-I healthy volunteer trials and CL coordinated MCT. Similarly, the audience expressed the desire to bring the EBF principles of harmonizing  also for other areas to ensure more quality for biomarker samples and other samples taken in clinical trials.

Go to: http://labman.europeanbioanalysisforum.eu/Slides/ for a free download of the presentations.


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