The European Bioanalysis Forum (EBF) is an organisation comprising bioanalytical scientists working within the

pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, Vaccine, vaccinate them, or alleviate s ...

R&D. Scope of the EBF is on

bioanalysis Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, ...

of small and large

molecules A molecule is a group of two or more atoms held together by attractive forces known as chemical bonds; depending on context, the term may or may not include ions which satisfy this criterion. In quantum physics, organic chemistry, and bioc ...

with ''bioanalysis'' being defined as: * Quantification of

drug A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhal ...

s and

metabolite In biochemistry, a metabolite is an intermediate or end product of metabolism. The term is usually used for small molecules. Metabolites have various functions, including fuel, structure, signaling, stimulatory and inhibitory effects on enzymes, ...

s in body fluids and tissues * Quantification of PD and safety

biomarkers In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, ...

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 their peers. Further, they share common practices on procedures, science,

Laboratory Information Management System A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations. K ...

s (LIMS), validation, quality ( GLP) and discuss new developments in industry.

History

The EBF was founded in the fall of 2006 at the initiative of twelve pharmaceutical companies, all of them having bioanalytical laboratory activities in Europe. The goal of bringing these companies together was to implement a platform for discussions of science and regulatory issues. Views and recommendations following from these discussions are either published in scientific journals, like for example on the controversial and much debated topic of incurred sample

reproducibility Reproducibility, also known as replicability and repeatability, is a major principle underpinning the scientific method. For the findings of a study to be reproducible means that results obtained by an experiment or an observational study or in a ...

or presented at international meetings. As of May 2010 the EBF consists of 28 member companies.

Meetings

The 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. The forum currently hosts two types of meetings:

Closed meetings

Twice a year the 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

The EBF organizes annual symposia to involve the bioanalytical community: pharmaceutical industry, academia, CRO, instrument providers and regulatory agencies. It is the intention of the organisation to inform their business partners and peers about the discussion held and agreements achieved and to open the forum for challenging procedures or techniques as well as for new regulatory requirements. The EBF has also reached out to participate in international scientific meetings representing the bioanalytical voice of the European pharmaceutical industry. Selective examples are: American Association of Pharmaceutical Scientists meetings, The Boston Society Applied Pharmaceutical Analysis meetings, and Canadian Validation Group meeting.

Organisation

Steering Committee

The organization is led by a steering committee elected from its members. The steering committee represents the EBF in international forums and sets the agenda for the closed and open meetings.

Interest groups

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

macromolecule A macromolecule is a very large molecule important to biophysical processes, such as a protein or nucleic acid. It is composed of thousands of covalently bonded atoms. Many macromolecules are polymers of smaller molecules called monomers. ...

s: drugs and biomarkers as well as

immunogenicity Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injectio ...

testing.

Sub groups

In 2008 the EBF started a subgroup that focuses on issues related to LIMS.

References

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External links

European Bioanalysis Forum
Analytical chemistry Pan-European scientific societies European medical and health organizations