Safe blood products world-wide: Successful collaboration of the Paul -Ehrlich-Institut with the World Health Organisation (WHO) to be continued
The “WHO Collaborating Centre for Blood Products and in vitro Diagnostic Devices” at the Paul-Ehrlich-Institut (PEI) started a collaboration with the World Health Organisation (WHO) as long ago as twelve years. Now, an extension of the collaboration has been confirmed for another four years. After the “WHO Collaboration Centre for Standardization and Evaluation of Vaccines”, the second WHO Collaboration Centre at the PEI has been confirmed by the WHO.
"We are happy that our commitment to the areas of vaccines and blood products, and thus the establishment of two important pillars of health has been confirmed world-wide", said Professor Klaus Cichutek. President of the PEI. The new period starts on 21 July 2017 and the confirmation is valid for another four years.
The activities of the members of staff of the PEI within the WHO Collaborating Centre Blood Products and in vitro Diagnostic Devices the head of which is Dr Dorothea Stahl, MBA, head of Section Transfusion Medicine at the PEI are many and varied. Important projects of the past four years include the development of reference materials for the identification of Zika-Virus-RNA, the detection of hepatitis E virus (HEV) or else mycoplasmas (pathogenic bacteria). Reference materials are required to standardise testing systems, thus making them usable. In addition, the pool of bacteria strains for the verification of detection methods for bacterial contaminations of blood cells has been extended.
As part of the collaboration in the "Blood Regulators Network" (BRN), members of staff of the PEI were among other things involved in the development of guidelines for the use of convalescence plasma in emergencies such as Ebola or influenza pandemics as well as the development of a Guidance Documents on the subject Management of Blood and Blood Components as essential medicines. The members of staff of the PEI, among other things, continued their contribution to the so-called Achilles Project ("Improving access to safe blood products through local production and technology transfer in blood establishment") of the WHO and the preparation of WHO Guidelines in the field of safety of blood products. A working package which has already been started and which will become another activity on which the members of staff of the PEI focus is the WHO project "Regulatory Systems Strenghtening". As part of their activities in the collaborating centre, the members of staff will also make use of their expertise in any health crises of international extent ("public health emergencies of international concern", PHEICs).
"Members of staff of the PEI are committed to various networks nationally and internationally and create structures which enable us to make use of synergies" says Dr Stahl. In this advantage, she sees one of the essential reasons for the successful work of PEI experts in as many as two WHO Collaborating Centres. In addition, the Paul-Ehrlich-Institut is contributing to an extensive work package, which includes the availability of safe and high-quality blood products, among other things in the Global Health Programme of the Federal Ministry of Health, the aim of which is international health.
"To use our expertise in regulation and research on biomedicines synergistically in various national and international collaborations, thus improving health care not only in Germany but also world-wide, is an important concern of ours", as Dr Stahl emphasised.
Members of staff from twelve sections at five divisions, Haematology/Transfusion Medicine, Basic Issues/Co-Ordination, Immunology, Microbiology, and Virology and the testing laboratory for in vitro diagnostic medical devices (PEI-IVD) contribute to the co-operation with the WHO.
Dr. Susanne Stöcker, Dr. Corinna Volz-Zang, Brigitte Morgenroth
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The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.
The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).