The Blood Products and Related Biologicals programme in the Quality and
Safety of Medicines team (QSM), Department of Essential Medicines and
Pharmaceutical Policies (EMP), World Health Organization (WHO) convened the 2nd
meeting with the WHO Collaborating Centres for Biological Standards and
Standardization (WHO CCs), i.e. the National Institute of Biological Standards
and Control (NIBSC), UK, the Paul-Ehrlich-Institute (PEI), Germany, and the
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration (FDA), USA. The meeting was kindly hosted, from 17 to 18 February
2009, by the Paul-Ehrlich-Institute in Langen, Germany. Professor Seitz, Head of
the WHO Collaborating Centre for Quality Assurance of Blood Products and in
vitro Diagnostic (IVD) Devices opened the meeting and welcomed the participants.
Professor Löwer, President of the PEI, gave an overview of the history of the
PEI and its current responsibilities, duties and research activities. Changes in
the regulation of medicines and IVDs in the European Community have influenced
the future responsibilities and duties of the institute. He outlined how new
products, such as gene transfer, cell therapy and tissue engineered products had
become new areas of responsibility of the PEI.
Dr Padilla (EMP/QSM) explained the global importance of Biological Reference
Preparations (BRPs) and underlined their role for the control of IVD tests
related to blood safety and the control of infectious disease markers. She
highlighted the objectives of the 2nd meeting which were to strengthen the
cooperation among the WHO Collaborating Centres for Biological Standards and
Standardization, and between the Centres and WHO, to continue the development of
the IVD plan, and to strengthen the development of BRPs.