Friday, December 11, 2009

EBF 2009 Presentations

The slide decks of the oral presentations of EBF's second open symposium "The Broadening Scope of Validation" have been made available at the conference site:

For login use the username and password as provided at the conference.

Thursday, December 10, 2009

FDA guideline on immunogenicity

On 3 December FDA released their draft guideline on immunogenicity testing on their website:

Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins

The consultation period is 60 days.

EMEA guideline on Bioanalytical Method Validation

The EMEA draft


has been made available on the EMEA website.
For downloading this important document use:

Deadline for comments: 31 May 2010

Wednesday, December 9, 2009


Welcome to the EBF Newsletter. The purpose of this blog managed by the European Bioanalysis Forum is to provide messaging to the bioanalytical community on important events and issues in the field of regulated bioanalysis.