INTRODUCTION & AIM OF THE WORKSHOP
Good Clinical Practices (GCP) are the cornerstone of ethical and scientific quality standards for clinical trials. As such, they are an integral part of the quality system of bioanalytical laboratories involved in sample management and analysis in support of clinical studies. Although the GCP regulations are not new, they continue to be refined or updated, resulting in growing differences in interpretation and application across the bioanalytical community.
The EBF has been discussing towards best practices on GCP for regulated Bioanalysis for many years, and a recently formed EBF GCP team took a deep dive to recommend towards a more harmonised interpretation of the GCP requirements for clinical sample analysis. In this workshop, the EBF team will share their work and invite for an open discussion in plenary or round table discussions towards a harmonised view on best practices for GCP in the bioanalytical lab.
MEETING AGENDA (details in PDF hyperlink below)
Considering the discussions in the EBF GCP team and the submitted abstracts, we were able to build an agenda touching on all challenges related to GCP for Bioanalysis. In addition, the round tables will be further prepared by pre-meeting surveys to the registered delegates to allow all to come prepared.
You can find the current version of the agenda here