In December the EMA presented their draft Guideline on Validation of Bioanalytical Methods and already early spring 2010, two important workshops were held discussing this guideline in particular (joint EBF / EUFEPS workshop) but also global harmonization (CVG / Canadian LC-MS Group). Again, as in Barcelona in 2009, there was a clear consensus among the many participants at this latter meeting in Montreal to strive towards a harmonized guideline or white paper. EBF presented their views on the draft EMA guideline and a harmonization process at the Montreal meeting in: EBF Perspective on the New EMA Guidelines on Bioanalytical Method Validation (BMV) and input on global BMV harmonization
Next to these meetings there are also a number of relevant publications in the April issue of Bioanalysis dealing with this topic:
- Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis
Philip Timmerman, Steve Lowes, Douglas M Fast, Fabio Garofolo
- International harmonization of bioanalytical guidance
Surendra K Bansal, Mark Arnold, Fabio Garofolo
- Towards harmonized regulations for bioanalysis: moving forward!
Peter van Amsterdam, Berthold Lausecker, Silke Luedtke, Philip Timmerman, Margarete Brudny-Kloeppel