The Björn Ekwall Memorial Award 2015

Introduction by Ada Kolman & lecture text by Michael Balls

A personal, and therefore unavoidably biased, review is given, of the significance of the contributions made by selected Scandinavian individuals, organisations and events, to the development of in vitro toxicology procedures as potential replacements for toxicity tests in laboratory animals. In addition to their wider significance, these contributions had a profound effect on whatever contributions I have been able to make, myself. Nevertheless, while there has been much progress in the last 35 years or so, and many lessons have been learned, there is still much to be done, especially as animal tests remain entrenched as the preferred methods which set the gold standards and make regulators feel comfortable. Many of the clues to dealing with the questions and concerns which plague hazard prediction and risk assessment have long been available, but they have been ignored, largely for reasons which have little to do with the science of toxicology and the need to maintain the highest scientific standards. I have little doubt that Björn Ekwall, whose memory I feel privileged to honour, would have agreed with that last statement.
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FRAME and the Validation Process

Michael Balls and Richard Clothier

FRAME’s historical involvement in the development of the principles of validation, whereby the reliability and relevance of a procedure are established for a specific purpose, and in the practical application of the process, is summarised, and examples of participation in various validation studies on in vitro tests are reviewed. Emphasis is placed on the need for a parallel invalidation process, and on the role of ATLA as a forum for objective reporting and discussion on all aspects of the validation process.
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Collaboration Between ZEBET, FRAME and ECVAM: FRAME’s Contribution to Establishing the Three Rs in Europe

Horst Spielmann

FRAME has more than any other institution contributed to the implementation of the Three Rs concept in Europe. The first step was achieved by establishing the European Research Group on Alternatives to Toxicity Testing (ERGATT), in which individual scientists in several European countries began to collaborate to promote the development and validation of in vitro toxicity tests in order to refine, reduce and replace the use of animals in toxicity testing. The first successful project was the start of the INVITOX in vitro toxicology database, which is today managed by ECVAM. Major milestones were the establishment in 1989 of ZEBET, the first national centre for alternatives, in Germany, and of ECVAM in 1991. In 1990, ERGATT and CAAT organised a workshop in Amden, Switzerland, at which European and US scientists developed the concept of experimental validation of toxicity tests, which today remains the basis for the independent, scientific validation process. ECVAM has applied this validation concept in all of its successful validation studies, which have provided in vitro toxicity tests that have been accepted for regulatory purposes by the EU Commission and by the OECD. By re-launching the ATLA journal in 1983, FRAME provided another powerful scientific tool for promoting the Three Rs in Europe and around the world. The close cooperation of scientists from FRAME, ZEBET and ECVAM has most effectively promoted and established the Three Rs as the basic scientific, ethical and legal concept for refining, reducing and replacing the use of experimental animals.
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