02 / 2013
After eight years of successful collaboration as a "WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices" the World Health Organization (WHO) has confirmed that it will continue working with the Paul-Ehrlich-Institut (PEI) for another four years. The President of the Paul-Ehrlich Institut, Professor Klaus Cichutek, is proud that the institute is being recognised in this way: "PEI has achieved this thanks to its in-depth expertise in a wide range of areas connected with regulatory affairs and scientific research as well as its sustained and reliable support of the WHO’s activities"
. During his visit to the PEI on 1 July 2013, Daniel Bahr, the German Federal Minister of Health, confirmed that "The quality of the PEI's work is very highly appreciated by the WHO."
"The renewed confirmation of the Paul-Ehrlich-Institut as a WHO Collaborating Centre is both an honour and an incentive for us to devote ourselves to the worldwide safety of blood products"
said Professor Rainer Seitz, Head of the Collaborating Centre and the Division of "Haematology and Transfusion Medicine". After all, many parts of the world still do not have an adequate supply of blood products, let alone products of guaranteed quality. However, blood products are vital for medical care. Thus, the high mortality rate among women in some developing countries due to heavy bleeding following child birth and infant mortality due to malaria could be reduced substantially by blood transfusions. Indeed, in areas of the world with a high prevalence of infectious diseases it is especially important to enforce high standards in order to guarantee the quality of blood products and to minimize the risk of viruses being transmitted, such as those causing hepatitis or AIDS.
For this reason, blood products are tested for viruses and bacteria to protect patients from possible infection. Reference preparations of the infectious pathogens which may contaminate blood products are used to guarantee the sensitivity and reliability of diagnostic assays. For this reason, the Paul-Ehrlich-Institut develops reference preparations for the WHO containing bacteria which grow in blood components and can jeopardise patients' health. Such preparations can be used for checking the reliability of screening tests: Contaminated blood products can thus be safely identified and eliminated. A major element in this context is the testing of microbiological reference preparations in international collaborative studies. Laboratories worldwide explore whether an assay will reliably identify any safety issues under various conditions.
Dispatch of reference preparations for the WHO
Source: PEI
In May 2010, Resolution WHA 63.12 of the World Health Assembly (WHA) on availability, safety, and quality of blood products came into force – Germany was the initiator of the resolution via the European Union. A consistent step which will advance the implementation of this resolution is the publication of the guidelines "Assessment Criteria for National Blood Regulatory Systems". Only authorities established within the respective country and working in a professional manner will be in a position to guarantee safe and high-quality blood products and a timely and just distribution of such products. The aim of the WHO is therefore to establish and support strong national authorities worldwide. As authors and representatives of the Paul-Ehrlich-Institut in the WHO Blood Regulators Network (BRN), Professor Rainer Seitz and Dr Margarethe Heiden have contributed to developing the guideline.
The work of the WHO Collaborating Centre has a variety of aspects: The Paul-Ehrlich-Institut initiates and organises standardisation projects for biological reference materials and participates in worldwide collaborative studies. Staff members of the Paul-Ehrlich-Institut actively participate in various expert meetings and working parties of the WHO and, together with other scientists, prepare regulatory documents (WHO guidelines). Last but not least, PEI seconds experts to Geneva on a regular basis. Colleagues from regulatory authorities from all over the world have the opportunity to extend their expertise on the regulation of blood products at the Paul-Ehrlich-Institut. The collaboration with the WHO is led by Professor Seitz with the assistance of Dr Gabriele Unger, who is responsible for the coordination of international relations, as well as staff members from eleven sections of four divisions at the PEI and the Testing Laboratory for In Vitro Diagnostic Devices (PEI-IVD).
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.).
Press Contact:
Paul-Ehrlich-Institut
Press Office
Dr. Susanne Stöcker, Dr. Corinna Volz-Zang, Brigitte Morgenroth
Paul-Ehrlich-Straße 51-59
63225 Langen
GERMANY
Telefon: +49 6103 77 1030
Telefax: +49 6103 77 1262
Email: presse@pei.de
Updated: 24.07.2013
