The role of the Steering Committee is to:
- decide, in consultation with the stakeholders, upon new collaborative studies within the Biological Standardisation Programme (BSP) and to nominate the Project Leaders and Scientific Advisors
- monitor the progress of BSP studies and provide scientific support
- approve the final study report
- advise the European Pharmacopoeia Commission on questions concerning the standardisation of biologicals.
- advise the BSP secretariat on the organisation and running of the BSP.
The Steering Committee meets twice a year, usually in January, and June or July. Between the meetings, reports can be approved by correspondence.
The Steering Committee is composed of 12 members and 1 observer. Its composition is as follows:
- the present Chairs of the European Pharmacopoeia Groups of Experts dealing with biologicals (Groups 6, 6B, 15, 15V)
- the present Chair of the Biologics Working Party (BWP) established by the Committee of Medicinal Products for Human Use (CHMP) and the present Chair of the Immunologicals Working Party (IWP) established by the Committee of Medicinal Products for Veterinary Use (CVMP) or their replacements as nominated
- one representative of European Medicines Agency (EMA)
- one representative of the European Commission
- at least two specialists in the field of biologicals for human use (usually one for vaccines and one for blood products or biotech products) and one specialist for biologicals for veterinary use. They are co-opted by the Steering Committee.
- the Director of the EDQM or a nominated replacement
Members take up their duty at the first Steering Committee meeting following their appointment. The Steering Committee elects a Chair for an initial three-year term with the possibility of re-election for one consecutive term.
- one representative of the Biologicals Division of the World Health Organization (WHO)
- for the duration of specific projects, the Steering Committee may appoint experts as ad hoc observers.