First Open EBF Symposium

Photo's taken at the 1st Open Symposium are made available via Picasa. For viewing go to:

http://picasaweb.google.com/europeanbioanalysisforum/EBF1stOpenSymposiumBurningIssuesInBioanalysis

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:

http://www.bioanalysis-forum.com/download/

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

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

GUIDELINE ON VALIDATION OF BIOANALYTICAL METHODS

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

http://www.emea.europa.eu/pdfs/human/ewp/19221709en.pdf

Deadline for comments: 31 May 2010

Welcome

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.