The European Medicines Agency (EMEA) Committee for Human Medical Products (CHMP) released a concept paper on the "Need of a Guideline for the Validation of Bioanalytical Methods" in December 2008. All interested parties were invited to provide input by the end of March 2009. Having collected and collated all input, the CHMP subcommittee released a Draft Guideline in December 2009 on their website, which is now in the cycle of consultation, until the end of May 2010, i.e. for final comments.

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 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.