User:Peteronium/European Bioanalysis Forum

The European Bioanalysis Forum (EBF) is an organisation comprised of bioanalytical scientists working within the pharmaceutical industry R&D. The scope of EBF is on bioanalysis of small and large molecules with 'bioanalysis' being defined as:


 * quantification of drug and metabolites in body fluids and tissues


 * quantification of PD and safety biomarkers amenable to conventional bioanalytical techniques


 * bioanalytical characterization of NBEs

Members discuss on regulatory issues and aspects (new guidelines, interpretation of existing guidelines) and present their joint opinion towards regulatory bodies and our peers. Furter, they share common practices - outside the IP area - on procedures, science, LIMS, validation, quality (GLP) etc. and discuss new developments in industry.

History
EBF was founded in the fall of 2006 at the initiative of 12 pharmaceutical companies, all of them having bioanalytical lab activities in Europe. The goal of bringing these companies together was to implement a platform for discussions of science, day-to-day procedures, business tools, technologies and last but not least regulatory issues. EBF currently hosts two types of meetings:

Working group meetings

Twice a year EBF brings together representatives all member companies to discuss subjects well prepared in advance. The topics range from procedural to regulatory often resulting in internal benchmarking or surveys. Next to these 'general' meetings, topic specific specialists meetings are also organized. All member companies assign one representative to these closed meetings.

Open meetings (symposium)

EBF organizes annual symposia to involve the bioanalytical community (pharmaceutical industry, academia, CRO, instrument providers, regulatory, etc.). It is the intention of the EBF to inform our business partners about the discussion held and agreements achieved and to open the forum for challenging procedures or techniques as well as for new regulatory requirements. EBF has also reached out to participate in international scientific meetings representing the bioanalytical voice of the European pharmaceutical industry. EBF intends to stimulate further harmonization of industry practices in bioanalysis, to bring a common understanding of the interpretation of regulatory issues and more clarity to the implementation of procedures in order to achieve best practices in the world of bioanalysis. Selective examples of EBF's active participation are: 2008 AAPS/FDA meeting, Boston APA meetings, 2009 CVG and 2009 AAPS/NBC meeting.

Sub- and interest groups
In 2008 EBF started a subgroup that focuses on issues related to LIMS systems. Further an Interest Group Macromolecules (EBF-IGM) was founded in 2008 to provide a platform for scientific exchange and harmonization of specific aspects for the bioanalysis of macromolecules.

Publications

 * Richard W Abbott, Margarete Brudny-Klöppel, Conference Report: European Bioanalysis Forum, Bioanalysis 2009 1:2, 273-276
 * Berthold Lausecker, Peter van Amsterdam, Margarete Brudny-Klöppel, Silke Lüdtke, Philip Timmerman, European Bioanalysis Forum and the way forward towards harmonized regulations, Bioanalysis 2009 1:5, 873-875
 * Philip Timmerman, Silke Luedtke, Peter van Amsterdam, Margarete Brudny-Klöppel, Berthold Lausecker, Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum, Bioanalysis 2009 1:6, 1049-1056