EMEA Draft Guideline on Validation of Bioanalytical Methods
April 15-16 • 2010 • Sheraton Hotel Brussels • Brussels • Belgium
The aim of this Workshop is to discuss the current scientific knowledge in the area of bioanalysis, the regulatory requirements and their subsequent translation into the work in the bioanalytical laboratory. Examples of topics to be discussed include the GLP-status of the process of method validation; acceptance criteria of methods to be used in the area of chromatography based and ligand-binding based assays; incurred sample reproducibility (ISR; study sample reanalysis for PK purposes; and re-integration, to list only a few).
The intention of this Workshop is to give scientists from industry and academia, managers and representatives of company regulatory functions the opportunity to discuss the new regulation with representative from regulatory authorities in Europe. Input for the Workshop Programme includes comments submitted to the organisers in the run-up phase to the event. All participants are invited to present their views and suggestions, based on own experience, during the discussion, and to support these proposals by experimental data.
The Workshop will open on Thursday, April 15, 2010, at 09:00, and it closes on Friday, April 16, 2010, at 14:30.