Development of WHO Biological Reference Preparations for Blood Safety-related in Vitro Diagnostic Tests. Report of the 2nd Meeting with the WHO Collaborating Centres for Biological Standards and Standardization, 17-18 February 2009
(2009; 28 pages)

Abstract

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.

 
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