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Thursday, March 7 • 1:00pm - 3:00pm
New Regulatory Science in System Toxicology - Part I: Is an Update Needed, What Would Be the Critical Elements and by When? FULL

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New regulatory science in system toxicology: is an update needed, what would be the critical elements and by when?

Regulatory toxicology is used to control about $10 trillion (£6.2 trillion) worth of worldwide trade in chemicals, drugs, pesticides, food and consumer products.

While Europe has been pursuing change under the label of alternative methods and the 3Rs (reduce, replace, refine) for more than two decades, it was only a 2007 National Research Council report on the subject that prompted serious efforts to change the US system. The 3Rs approach had suggested either optimising animal tests (fewer animals or less pain and distress) or replacing traditional tests with in vitro or in silico models for harmonization.

The answer emerging in Europe is to combine various information sources in integrated (or intelligent) testing strategies (ITS). Despite the enormous possible impact this could have with EU legislations like REACH or the testing ban for cosmetic ingredients, efforts to further this are still limited. The answer emerging in the US is to adopt a new, molecular description of toxic action based on pathways of toxicity (PoT) – the biomolecular pathways that lead to a cell being harmed. This approach represents a paradigm shift in toxicity testing – identifying a substances effect on harmful cellular pathways, rather than interpreting effects on cell lines or entire organisms.

Synergies exist between these two approaches and two economic partners. Joint efforts to keep
leadership and achieve results are seek.




avatar for Mr. Francois Busquet

Mr. Francois Busquet

Europe Policy Coordinator at Center for Alternatives to Animal Testing (CAAT)
François Busquet studied Biotechnologies at the ENSTBB in France. He graduated from the TU Dresden, completing his PhD at the MerckSerono group in Germany on the development of a new screening assay to detect proteratogenic compounds using zebrafish embryos. After his studies, he worked in ECVAM at the Joint research Centre (European Commission) in Italy on the coordination of the OECD validation study of the zebrafish embryo toxicity... Read More →

avatar for Dr. Robert Barouki

Dr. Robert Barouki

Professor at the University Paris Descartes
Robert Barouki is a biochemist and molecular biologist whose main focus during the last fifteen years has been understanding the mechanisms of toxicity of environmental pollutants such as dioxin. In particular, he has studied the biological consequences following the activation of the dioxin receptor AhR, Initially Dr. Barouki focused on consequences related to cellular stresses such as oxidative stress and endoplasmic reticulum stress... Read More →
avatar for Dara Corrigan

Dara Corrigan

FDA Europe Office Director, FDA
Dara Corrigan heads the FDA’s Europe Office, located in Brussels. Ms. Corrigan serves as the FDA’s chief representative to the European Union (EU), working directly with the European Commission, European Medicines Agency and European Food Safety Agency. She also serves as liaison to FDA counterpart agencies in the 27 EU member States and in European countries outside the EU.  In addition, Ms. Corrigan serves as FDA’s link... Read More →
avatar for Rex Fitzgerald

Rex Fitzgerald

Regulatory toxicology expert at Swiss Centre For Applied Human Toxicology
"Rex FitzGerald graduated in zoology from Trinity College (Dublin, Ireland) and received a D.Phil in Biological Sciences at Sussex University (UK). He became a Diplomate of the American Board of Toxicology (DABT) in 1990 and was Head of Reproductive Toxicology at Ciba-Geigy, Stein, before setting up his own consulting business in toxicology in 1996, providing documentation and regulatory advice in nonclinical and clinical toxicology to the... Read More →
avatar for Thomas Hartung

Thomas Hartung

CAAT US Director
Thomas Hartung, MD PhD, is professor and chair for toxicology, pharmacology, molecular microbiology, Evidence-based Toxicology and immunology at Johns Hopkins Bloomberg School of Public Health, Baltimore MD, and University of Konstanz, Germany. He directs the Centers of Alternative to Animal Testing (CAAT) of both universities. From 2002-2008 he led the European Center for the Validation of Alternative Methods (ECVAM) of the European Commission's... Read More →
avatar for Adriano Henney

Adriano Henney

Programme Director German Virtual Liver Network
Dr Henney obtained a PhD in Medicine and has 23 years’ research experience in cardiovascular disease in laboratories in London, Cambridge and Oxford. His interests have focused predominantly on atherosclerosis, with studies ranging from pathology, through molecular and cellular biology to molecular genetics. In 1997, he was recruited by Zeneca Pharmaceuticals from a Senior Fellowship position leading his own molecular genetics group in... Read More →
avatar for Ms. Emily McIvor

Ms. Emily McIvor

Senior Policy Adviser for Humane Society International/Europe
Emily McIvor has worked on animal welfare issues at European Union level for many years, specialising in those concerning the use of animals in research and testing. As one of the lead animal welfare lobbyists in political negotiations of the EU Cosmetics Directive 7th Amendment, the Registration, Evaluation and Authorisation of Chemicals (REACH) regulation, and most recently the revision of Europe's legislation for the protection of animals... Read More →

Vittorio Prodi, MEP

Chair of the Sky and Space Intergroup

Thursday March 7, 2013 1:00pm - 3:00pm
European Parliament A3H1

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