5th GCC Closed Forum for Bioanalysis (at the EBF)

The 5th GCC Meeting for Bioanalysis at the EBF was a whole day meeting taking place on November 15, 2011 in Barcelona, Spain.It was chaired by Tim Sangster and attended by 29 CRO representatives representing 24 European CRO members

Topics Discussed at this meeting:

  • ISR in multi-analyte assays: aim of reaching a consensus on the method of sample selection and the number of samples to be assessed - led by Tim Sangster and John Maltas
  • Regulatory requirements for GCP (training, contracts etc.) - led by Jim Hillier and Jaap Wieling
  • Regulation of QA/Bioanalytical Consultants and provide a list of recommendations to sponsors for hiring a "qualified" consultant - led by Petra Struwe
  • Assay qualification and validation: attaining clear definitions in relation to biomarker assays - led by Rachel Green and Richard Houghton
  • The new EMA Bioanalytical Guidance published August 1 2011 - led by Tammy Harter and Fabio Garofolo

A Meeting Report/White Paper including all the resolutions of this GCC Closed Forum will be generated, signed off by all the official representatives and published shorlty!