title: Workshop/conference report on EMA draft guideline on validation of bioanalytical methods.
abstract: This is a summary report of the workshop on the EMA Draft Guideline on Validation of Bioanalytical Methods held April 15-16th 2010 in Brussels (Belgium) and jointly organised by the European Bioanalysis Forum (EBF) and the European Federation for Pharmaceutical Sciences (EUFEPS). Aim of the workshop was to discuss the current scientific knowledge in the area of bioanalysis, the regulatory requirements with special focus on the new Draft Guideline and their subsequent implementation to the work in bioanalytical laboratories. Comments on the Draft Guideline were presented and discussed with representatives from regulatory authorities in Europe. The workshop started with discussions on the scope of the Guideline and the need for implementation of GLP. A special focus was set on method validation of chromatographic procedures and subsequent study sample analysis. In addition, requirements for ligand-binding assays were briefly addressed. Intention of this Conference Report is to summarise important aspects of the discussions in order to draw certain conclusions, and to identify points which remain open and may require clarification at a later stage.
authors.affiliation: SocraTec CSC GmbH, Oberursel, Germany. h.h.blume@t-online.de
authors.forename: Henning
authors.initials: H
authors.lastname: Blume
authors.forename: Erich
authors.initials: E
authors.lastname: Brendel
authors.forename: Margarete
authors.initials: M
authors.lastname: Brudny-Klöppel
authors.forename: Sylvia
authors.initials: S
authors.lastname: Grebe
authors.forename: Berthold
authors.initials: B
authors.lastname: Lausecker
authors.forename: Gabriele
authors.initials: G
authors.lastname: Rohde
authors.forename: Christoph
authors.initials: C
authors.lastname: Siethoff
mesh_terms: D002626:Chemistry, Pharmaceutical; D017408:Guidelines as Topic