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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