The Wildbad Kreuth initiative: European current practices and recommendations for optimal use of blood components.

With the aging population in Europe it is anticipated that the growing demand for blood products will not be met by the estimated supply. Therefore up-to-date recommendations for optimal administration of blood products in hemotherapy are needed. Ten years after the first meeting on optimal use of blood products at Wildbad Kreuth, Germany, a second symposium was organized to convene leading experts from the clinical, regulatory and economic perspective. The aim was to re-evaluate the existing state of hemotherapy, identify areas where further studies are needed, and to provide up-dated recommendations. A preparatory survey by questionnaire concerning guidelines, quality management in clinical use of blood products, provision of products in the individual countries and re-evaluation of the 1999 Wildbad Kreuth recommendations was completed in advance. The second Kreuth Meeting in April 2009 was attended by 110 experts in transfusion medicine, regulators and regulatory authorities from 38 countries. By consensus, 20 new recommendations were adopted. Most of the 1999 recommendations were found to still be valid 10 years later. But their realization and implementation on the levels of clinical practice, regulatory authorities and health policy decision makers is still lagging behind leaving an important task to accomplish. The Kreuth initiative toward optimal use of blood products should continue.

The consistency approach for the quality control of vaccines.

Current lot release testing of conventional vaccines emphasizes quality control of the final product and is characterized by its extensive use of laboratory animals. This report, which is based on the outcome of an ECVAM (European Centre for Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy) workshop, discusses the concept of consistency testing as an alternative approach for lot release testing. The consistency approach for the routine release of vaccines is based upon the principle that the quality of vaccines is a consequence of a quality system and of consistent production of lots with similar characteristics to those lots that have been shown to be safe and effective in humans or the target species. The report indicates why and under which circumstances this approach can be applied, the role of the different stakeholders, and the need for international harmonization. It also gives recommendations for its implementation.

AGAATI/ECVAM Workshop on the Validation of Alternative Methods for the Potency Testing of Vaccines.

The workshop on validation of alternative methods for the potency testing of vaccines was organised by ECVAM (European Centre for the Validation of Alternative Methods) and AGAATI (Advisory Group on Alternatives to Animal Testing in Immunobiologicals), and it was held in Angera, Italy, on 14-16 November 1997 under the co-chairmanship of Coenraad Hendriksen (RIVM, Bilthoven, The Netherlands) and Jean-Marc Spieser (EDQM, Strasbourg, France). The 17 participants, all experts in vaccine quality control and/or validation procedures, came from international regulatory bodies and organisations, national control laboratories and vaccine manufacturers. The aim of the workshop was to discuss, in an informal atmosphere, the complex issue of guidelines for the validation of alternative methods to potency testing of vaccines in laboratory animals, in particular: a) to review existing guidelines for validation; b) to discuss specific guidelines for the validation of alternative methods to the potency testing of vaccines and to agree on strategies for the preparation of guidelines; and c) to discuss and make recommendations for the implementation of validated alternative methods for regulatory purposes. The outcome of the discussions and the recommendations will be published in the ECVAM workshop series in ATLA in late 1998.