Harmonization of Bioanalytical Method Validation guidances

When the EMA (formerly known as EMEA) presented it's concept paper on the need of a bioanalytical method validation guideline, the bioanalytical community was worried about the consequences of having multiple, potentially contradicting, guidelines from major economies. This lead to the strong feeling to move towards the direction of harmonization of BMV guidelines, basically to come to one guideline. This wish was clearly expressed by the hundreds of attendees at the EBF 2nd open conference in Barcelona last year.

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

An idea that was seeded at the Barcelona 2009 meeting: set-up an international group to foster and manage processes towards harmonization of BMV guidances, was extensively discussed and further developed at the Montreal CVG meeting. A group named 'Global BMV Consortium (GBC)' with representatives of AAPS, APA, CVG and EBF is being set-up for this purpose. The GBC would like to get a number of representatives from international BA organisations from other continents then North America and Europe on board and is reaching out to identify key organizations that represent the bioanalytical community in their region/continent in accordance with the current 4 founding members. It is the intention to publish the activities of this group at one or a few websites.

Dried Blood Spots

Bioanalysis and Dried Blood Spots (DBS) first entered the agenda of EBF in June 2008 and has been repeatedly discussed ever since that first presentation in Basel. There was a full conference session dedicated to DBS during the 2009 open EBF conference in Barcelona and a one and a 3/4 day workshop is currently in preparation. For more information on this workshop in Brussels check out EBF's dedicated DBS conference webpages.

Final Draft Program DBS Workshop

The program of this two day EBF workshop in Brussels on the value and use of Dried Blood Spots is approaching its completion. The meeting will start at 8:30 on Thursday 17 June and will close at 14:30 on Friday 18 June.

Sessions:
- DBS in the non regulated environment
- Combined poster & tutorial
- Combined toxicology & regulatory/QA aspects
- Bioanalytical & DBS: applications
- Clinical environment
- Bioanalytical & DBS: tools

The detailed final draft can be downloaded from the conference site.