Role

The role of the Steering Committee is to:

• decide, in consultation with the stakeholders, on 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 either June or July. In the interim, reports can be approved by correspondence.

Composition

The Steering Committee is composed of the following members and observers:

Members

• the current Chairs of the European Pharmacopoeia Groups of Experts dealing with biologicals (Groups 6, 6B, 15 and 15V);
• the current Chairs of the Biologics Working Party (BWP), established by the Committee of Medicinal Products for Human Use (CHMP), and Immunologicals Working Party (IWP), established by the Committee of Medicinal Products for Veterinary Use (CVMP), or their replacements as nominated;
• one representative from the European Medicines Agency (EMA);
• one representative from 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, co-opted by the Steering Committee;
• the Director of the EDQM or a nominated replacement.

Members take up their post 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 additional term.

The current Chairs of relevant Ph. Eur. working parties involved in biologicals (e.g. P4BIO or MAB) are ad hoc members of the Steering Committee and are invited to participate in meetings when a topic from their working party is on the agenda.

Observers

• a representative from the unit for Norms and Standards for Biological Products of the World Health Organization;
• for the duration of specific projects, the Steering Committee may appoint experts as ad hoc observers.