EBF meeting on DBS in drug development

Announcement / Update

A DBS sub team of the European Bioanalysis Forum is moving forward with the preparations of holding a meeting focused on Dried Blood Spots. In this meeting EBF intends to bring together experts from all areas involved in this technique (Bioanalysis, Toxicology, Pharmacokinetics, Central labs, Regulatory authorities and Vendors) to connect and discuss the potential application of Dried Blood Spots in drug development.

Location: Sheraton Brussels Hotel, Belgium
Date: 17 - 18 June 2010

For future updates follow this newsletter or one of the following web sites:

EBF: http://www.e-b-f.eu/ Portal: http://sites.google.com/site/ebfdbs/

EBF-EUFEPS meeting on draft EMEA guidance on BMV

Announcement / Update

EBF and EUFEPS are jointly setting up a conference to present and discuss the recently released draft guideline on Bionalytical Method Validation by the EMEA.

The meeting is scheduled for 15 - 16 April 2010 and will be held Brussels, Belgium.

For future updates follow this newsletter or one of the following web sites:



EBF: http://www.e-b-f.eu/ EUFEPS: http://www.eufeps.org/
Flyer: http://sites.google.com/site/emeabmv/home

4th Workshop on Recent Issues in Regulated Bioanalysis

In continuation of 2007 - 2009 workshops, the 4th Regulated Bioanalysis Workshop (Montreal April 21-23 2010) will discuss Global Harmonization of Bioanalytical Method Validation (BMV) and Sample Analysis Guidelines with 5 major Worldwide Regulatory Agencies: US FDA, UK MHRA, Brazil ANVISA, Europe EMEA guideline representative, and Health Canada representative.

The main purpose of this event is to Discuss, Review, Share Perspectives, Provide Potential Solutions and Agree upon a Consistent Approach on the Recent Issues in Regulated Bioanalysis.

The workshop will be held from April 22-23, 2010 in Montreal, Canada
Short Courses are on April 20-21, 2010 and the venue is the Hotel Marriott Chateau Champlain.

Detailed information can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php

Pictures 2nd Open EBF Symposium

Photos taken at the second open EBF symposium held 2 - 4 December 2009 in Barcelona have been made available for viewing and downloading on Picasa:

http://picasaweb.google.com/europeanbioanalysisforum/EBF2ndOpenSymposiumTheBroadeningScopeOfValidation#

Addendum to ICH S6

The addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals has been published and is open for comments. The document can be downloaded from:

EMEA - http://www.emea.europa.eu/pdfs/human/ich/030295enfin.pdf
FDA - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf
ICH - http://www.ich.org/LOB/media/MEDIA503.pdf

Deadline for comments is February 2010

Dried Blood Spots

An EBF-DBS sub team is preparing a meeting focused on Dried Blood Spots. In this meeting EBF intends to bring together experts from all areas involved in this technique (Bioanalysis, Toxicology, Pharmacokinetics, Central labs, Regulatory authorities and Vendors) to connect and discuss the potential application of Dried Blood Spots in drug development. More details will follow soon

The meeting will be held in Brussels in the May/June 2010 timeframe

EBF-EUFEPS-EMEA meeting

EBF will together with the EUFEPS be organising a meeting on EMEA draft guidance on bioanalytical method validation.

The meeting is scheduled for the third week in April and will be held in Brussels.

Further and more detailed information will follow by the end of January.

Links:

EBF: http://www.e-b-f.eu/conferences.php
EUFEPS: http://www.eufeps.org
EMEA BMV: http://www.emea.europa.eu/pdfs/human/ewp/19221709en.pdf