Genotoxic Compounds

The conference focuses on providing the latest developments and implications in the assessment and regulation of genotoxic compounds and is designed to meet the diverse needs of various industries. It will cover a wide range of topics including test methods, guidelines, and the modelling and prediction of genotoxicity.

Garantierte Durchführung
13.02. — 14.02.2025
Online Conference
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ÜbersichtProgrammReferent:innenVeranstaltungsortPreise & Leistungen

Übersicht

Recent developments and implications for assessment and regulation

Again in 2025: 3rd International Akademie Fresenius Conference "Genotoxic Compounds"

This compact conference on genotoxic compounds offers a unique platform for interaction among regulatory, industrial, and scientific professionals and focuses on agrochemicals, chemicals, biocides, cosmetics, pharmaceuticals, food, feed, and food contact materials. Attendees can expect to gain valuable insights into the latest advancements in regulation, quantitative risk assessment, test methods and guidelines, to understand the implications for their specific industries, and to learn about modelling and prediction. This event promises to be a crucial opportunity to stay informed and updated in this rapidly evolving field.

Highlights:

Regulatory developments

  • Genotoxic compounds in EU food safety policy
  • Case studies: Pyrrolizidine alkaloids (PA) and 2-chloroethanol stories
  • Novelties for mutagenicity under REACH and CLP
  • Germ cell mutagenicity

Quantitative risk assessment

  • Results of the BfR Symposium on strategies and tools for quantitative risk assessment
  • Activities of the GTTC on quantitative analyses

Development of test methods and guidelines

  • Error-corrected next generation sequencing (ecNGS) and how it is being used
  • Transcriptomic biomarkers
  • ToxTracker assay to investigate the mode-of-action of genotoxic compounds
  • The PARC project
  • Novel methodology to assess genotoxicity in FCM

Modelling and prediction of genotoxicity

  • EFSA Pesticides Genotoxicity Database
  • The new OECD QSAR assessment framework
  • Plant protection QSAR models through data sharing and regulatory review

Who should attend this conference?

Professionals working in the fields of:

  • Toxicology
  • Hazard, exposure and risk assessment for human health
  • Registration & regulatory affairs
  • Research and development
  • Legal and general counselling

Sectors that should take part:

  • Agrochemical industry
  • Biocide industry
  • Chemical industry
  • Pharmaceutical industry
  • Cosmetic industry
  • Food and feed industry
  • Packaging industry
  • Research institutes
  • Regulatory authorities
  • Testing laboratories and contract research organisations (CROs)
  • Consultancies
  • Professional associations

Picture Credit: © Sashkin – Fotolia.com

 

Programm

Thursday, 13 February 2025

Timings are in Central European Time CET.



Afternoon Session | 12:30 – 17:50 CET
Welcome address by Akademie Fresenius and introduction by the Chairs

Krista Meurer, BASF, Germany
Carsten Kneuer, German Federal Institute for Risk Assessment (BfR), Germany

Regulatory developments
Genotoxic compounds in EU food safety policy, with focus on contaminants

Frans Verstraete, European Commission, Belgium

Case studies
  • Pyrrolizidine alkaloids story
  • 2-chloroethanol story

Catherine Mahony, Procter & Gamble, UK
Stefan Pfuhler, Procter & Gamble, USA

Current changes in information requirements for mutagenicity under REACH
  • REACH – revision 2022 related to information requirements for mutagenicity
  • REACH – ECHA’s Member State Committee decisions related to the test strategy for mutagenicity
  • News in OECD Test Guidelines and current Standard Project Submission Forms (SPSF)

Ulrike Gündel, German Federal Institute for Risk Assessment (BfR), Germany

Update of the UN GHS classification and labelling of chemicals

Raffaella Corvi, European Commission Joint Research Centre (JRC), Italy

Quantitative risk assessment
Risk assessment of genotoxic compounds: Opportunities, challenges and perspectives
  • So far, genotoxicity assessment is widely hazard-based
  • Controversial discussion about the need for a paradigm shift
  • BfR has hosted a symposium to discuss opportunities, challenges and perspectives
  • Major results from the symposium

Benjamin Sachse, German Federal Institute for Risk Assessment (BfR), Germany

Update on HESI (Health and Environmental Sciences Institute) and the activities of the GTTC’s (Genetic Toxicology Technical Committee) quantitative analyses workgroup

Paul A. White, Health Canada, Canada

Development of test methods and guidelines
The coming revolution: application of error corrected next generation sequencing (ecNGS) to quantify and characterise mutations
  • ecNGS: Promises and challenges for genotoxicity and cancer risk assessment
  • How Duplex Sequencing is being used to advance mutagenesis and carcinogenesis research

Francesco Marchetti, Health Canada, Canada

Advances in the use of transcriptomic biomarkers for genotoxicity assessment: From validation to implementation
  • The journey of the TGx-DDI transcriptomic biomarker as it proceeds through the US FDA qualification process
  • State of the science of applying TGx-DDI in integrated testing for qualitative and quantitative applications
  • Work to expand the context of use and define suitable application domains (beyond TK6 cells)

Carole Yauk, University of Ottawa, Canada



Friday, 14 February 2025

Timings are in Central European Time CET.



Morning Session | 9:30 – 12:40 CET
Development of test methods and guidelines
Update on the applications of the ToxTracker assay to investigate the mode-of-action of genotoxic compounds

Giel Hendriks, Toxys, The Netherlands

PARC project to develop an AOP-based IATA for genotoxicity – where are we today and where do we want to go
  • Adverse outcome pathways, NAMs for genotoxicity, integrated approaches for testing and assessment

Birgit Mertens, Sciensano, Belgium

Novel methodology to assess genotoxicity in food contact materials

Maricel Marin-Kuan, Nestlé Research, Switzerland

Modelling and prediction of genotoxicity
Update and extension of the EFSA Pesticides Genotoxicity Database
  • The availability of high-quality databases covering a broad chemical space and genotoxicity endpoints can provide the foundation for improving the confidence of (Q)SAR models and read-across
  • Genotoxicity information of pesticide residues, including active substances and their metabolites, needs to be accessible, unambiguous and well-curated
  • EFSA founded a collaborative project intended to: transfer the existing EFSA pesticides genotoxicity database in IUCLID, update the database, extend the database on in vitro micronucleus (IVMN) tests

Juan Parra Morte, European Food Safety Authority (EFSA), Italy

The new OECD QSAR assessment framework (QAF): Guidance for assessing QSAR models and predictions
  • Uptake of (Q)SAR predictions of chemical hazards requires establishing confidence
  • The QAF enables regulators to evaluate (Q)SARs consistently and transparently and provides clear requirements to meet for (Q)SAR developers and users
  • Similar principles may be extended to other NAMs to facilitate regulatory uptake

Olga Tcheremenskaia, Istituto Superiore di Sanità (ISS), Italy

Plant protection QSAR models through data sharing and regulatory review

Markus Frericks, BASF, Germany

Referent:innen

 

Name

Unternehmen

Corvi

Raffaela Corvi

European Commission Joint Research Centre (JRC), Italy

Raffaella Corvi has a PhD in Biological Sciences and has been working at the Joint Research Centre of the European Commission since 2001 where she established the activities in the area of genotoxicity and carcinogenicity. In 2003 she was seconded to the OECD Test Guideline Programme in Paris. Currently, she conducts activities that evaluate innovative and integrated approaches to assess chemical safety across sectors and support their regulatory implementation, while also promoting the 3Rs across multiple regulatory sectors. She is currently leading a working group for the revision of germ cell mutagenicity classification criteria at the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and is a member of several European and international committees (e.g. co-chair of the European Partnership for Alternative Approaches to Animal testing (EPAA) project platform, OECD expert groups, HESI Genetic Toxicology Technical Committee, etc.).

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Frericks

Markus Frericks

BASF, Germany

Markus Frericks is a Biologist and European Registered Toxicologist, working as a Regulatory Toxicologist at BASF in Limburgerhof. He is the Vice Chair of the Working Group on Computational Toxicology of the German Society of Toxicology (GT) and the Chair of the CropLife Europe Working Group on Genotoxicity-QSAR.

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Gündel

Ulrike Gündel

German Federal Institute for Risk Assessment (BfR), Germany

Ulrike Gündel studied Biochemistry and Toxicology. She has been working as a Scientist in the Safety of Chemicals Unit of the Department of Chemicals and Product Safety at the German Federal Institute for Risk Assesssment (BfR) in Berlin since 2015 and has focussed on the endpoint mutagenicity. She is involved in several national and international expert groups related to mutagenicity such as OECD expert groups and the current UN GHS informal working group for discussion of the classification criteria of germ cell mutagenicity. Moreover, she acts as ECHA Member State Committee (MSC) and Risk Assessment Committee (RAC) adviser for mutagenicity related issues.

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Hendriks

Giel Hendriks

Toxys, The Netherlands

Giel Hendriks has a PhD in molecular cell biology from Utrecht University and worked for four years as a post-doctoral fellow at Leiden University, studying the relationship between DNA damage and gene mutations. After this he moved to the Leiden University Medical Center to develop in vitro reporter systems to understand the mechanisms of genotoxicity. Currently, he is the CEO of Toxys, a contract research organisation (CRO) he started in 2014. During the past years, Toxys has developed various in vitro assays to ensure the safety of novel medicines, chemicals and consumer products without the use of animals.

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Kneuer

Carsten Kneuer

German Federal Institute for Risk Assessment (BfR), Germany

Carsten Kneuer is a Toxicologist and the Head of the Unit “Toxicology of Active Substances and their Metabolites“ in the Pesticides Safety Department of the German Federal Institute for Risk Assessment. His group is evaluating the mammalian toxicology of pesticides within the EU assessment framework and actively involved in various projects aimed at the advancement of our risk assessment practice.

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Catherine Mahony

Procter & Gamble, UK

Catherine Mahony is a Principal Scientist for Procter & Gamble Technical Centres, UK with more than 24 years of Product Safety experience in the consumer product industry. Within that role, she is responsible for providing scientific leadership for assessments aimed at characterising the safety of ingredients and new products. She is the author or co-author on a number of publications and is a member of both the UK register of Toxicologists and the European Register of Toxicologists. She is also a member of the British Toxicology Society.

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Marchetti

Francesco Marchetti

Health Canada, Canada

Francesco Marchetti is a Senior Research Scientist at Health Canada and Adjunct Research Professor at Carleton University. He chairs the Germ Cell workgroup of the Health and Environmental Science Institute’s Genetic Toxicology Technical Committee and the International Workshop on Genotoxicity Testing’s Workgroup on error corrected sequencing. He is a member of the Organisation for the Economic Co-Operation and Development Expert Group on Genotoxicity Testing and serves on the editorial boards of Environmental and Molecular Mutagenesis and Mutagenesis. Francesco was President of the Environmental Mutagenesis and Genomic Society (EMGS) in 2022 and received the Excellence in Science Award from the Genetic Toxicology Association in 2024.

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Marin-Kuan

Maricel Marin-Kuan

Nestlé Research, Switzerland

Maricel Marin-Kuan is In Vitro Toxicology Specialist within the Nestlé Institute of Food Safety & Analytical Sciences at Nestlé Research in Lausanne-Switzerland. Maricel has been working at Nestlé since 2002, with key scientific contributions in the safety-by-design area bringing in vitro solutions to food quality and safety challenges for prioritization and decision-making. Involved in the packaging safety area since 2010 with the application of multidisciplinary tools to assess the safety of new packaging material using qualified in vitro tools. External collaborations with academia and industry on various food safety issues.

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Mertens

Birgit Mertens

Sciensano, Belgium

Birgit Mertens obtained her Master in Pharmaceutical Sciences and PhD in Neuropharmacology from the Vrije Universiteit Brussel in Belgium. She joined Sciensano in 2010 and is currently a Senior Toxicologist and team leader of the Risk and Health Impact Assessment Service. She coordinates and participates in multiple (inter)national research projects and activities on the genotoxicity of physical and chemical agents, focusing on food contaminants and developing and applying new approach methodologies. She is the National Coordinator of the Test Methods Programme both at the European and OECD level and the Belgian contact point for the Preliminary Assessment of the Regulatory Relevance of Alternative Methods (PARERE) network. She is also a member of the OECD genotoxicity expert group. She participates in different (inter)national working groups and scientific committees on hazard and risk assessment and is the current president of the Belgian Environmental Mutagenesis Society.

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Meurer

Krista Meurer

BASF, Germany

Krista Meurer has been a Regulatory Toxicologist for Crop Protection at BASF since 2008. In support of European and global registrations, she is responsible for human health risk assessment for pesticide products and active substances. Based on 10 years experience as a Study Director in contract research, Krista has a special interest in genetic toxicology testing and is a co-chair of the CropLife Europe genotoxicity expert group as well as member of the Health and Environmental Sciences Institute (HESI) Genetic Technical Committee (GTTC).

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Parra Morte

Juan Parra Morte

European Food Safety Authority (EFSA), Italy

Juan Parra Morte has been Toxicologist in the Pesticide Peer Review Unit of EFSA since 2008. He has been actively involved in the assessment of pesticide active substances, their metabolites and impurities, including the EFSA PPR, the OECD Guidance on Residue Definition and EFSA's outsourced projects on the Genotoxicity Database and QSAR and Read-Across for the genotoxicity of metabolites. He has also been involved in supporting the EFSA Working Group on Genotoxicity, being a co-author of the EFSA Scientific Committee Guidance and Statements regarding genotoxicity since 2017.

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Pfuhler

Stefan Pfuhler

Procter & Gamble, USA

Sachse

Benjamin Sachse

German Federal Institute for Risk Assessment (BfR), Germany

Benjamin Sachse is a European Registered Toxicologist and has been working as a Scientific Officer in the Food Safety Department at the German Federal Institute for Risk Assessment (BfR) since 2016. He is responsible for the risk assessment of botanical ingredients in foods and has a background in genotoxicity assessment for several years.

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Tcheremenskaia

Olga Tcheremenskaia

Istituto Superiore di Sanità (ISS), Italy

Olga Tcheremenskaia is a Senior Researcher at Environment and Health Department of the Italian National Institute of Health (ISS) and has worked at this Institute since 2001. She has coordinated several projects funded by EFSA and ECHA, as well as co-coordinating the OECD (Q)SAR Assessment Framework working group. Her current activities include serving as the Italian representative in several OECD expert groups, including the OECD IATA case studies project, the OECD QSAR Toolbox Management Group, and the OECD Emerging Science in Chemicals Assessment (ESCA) expert group. She participates actively in the EU_PARC project and coordinates the Task on improving existing computational methodologies within the EU_WILDPOSH project and the EFSA project on updating the EFSA genotoxicity database. A major part of her research focuses on chemical risk assessment using animal-free methods, particularly New Approach Methodologies (NAM) based on in silico approaches such as (Q)SAR models, read-across, and AOPs. She also has extensive experience managing toxicological data and developing relational databases.

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Verstraete

Frans Verstraete

European Commission, Belgium

Frans Verstraete works in the European Commission in the Directorate General for Health and Food Safety (DG SANTE) and is responsible for legislation on contaminants.

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White

Paul A. White

Health Canada, Canada

Paul A. White obtained his BSc in microbiology and immunology, and PhD in environmental toxicology, from McGill University in Montreal. He conducted post-doctoral research at US EPA facilities in Rhode Island and North Carolina; investigating the mutagenic hazards of municipal wastewaters. He joined Health Canada in 1999 and is currently a senior research scientist in the Environmental Health Science and Research Bureau. In 2002 he was appointed Professor of Chemical and Environmental Toxicology in the Department of Biology at the University of Ottawa. His current work investigates the mutagenic and carcinogenic hazards of complex mixtures, the design and validation of in vitro tools for genetic toxicity assessment, the use of molecular biomarkers for mutagen exposure assessment, and the application of quantitative methods for interpretation of genetic toxicity dose-response data. He has published over 125 peer-reviewed papers, and his work has been cited over 6700 times. He currently serves on the editorial boards of Environmental and Molecular Mutagenesis, Mutation Research Reviews, Genes and Environment, and Food and Chemical Toxicology, and he is currently the vice-president of the International Association of Environmental Mutagenesis and Genomics Societies (IAEMGS).

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Yauk

Carole Yauk

University of Ottawa, Canada

Carole Yauk was the lead scientist of the Genomics Laboratory in the Environmental Health Science and Research Bureau at Health Canada for 18 years. She joined the University of Ottawa’s Department of Biology as a professor in September 2020, where she holds the Tier 1 Canada Research Chair in Genomics and the Environment. Her research broadly focuses on multi-sector collaborative efforts to develop and implement genomic tools for human health risk assessment of environmental chemical exposures. She is involved in various international consortia to advance this area, including within the Health and Environmental Sciences Institute (a global non-profit), where she currently serves as Chair of the Board of Trustees. She is a Canadian Delegate to the Organisation for Economic Co-operation and Development (OECD), participating in the Advisory Group on Emerging Science in Chemicals Assessment. She is Past-President of the Environmental Mutagenesis and Genomics Society and an editorial board member of several journals focused on mutagenesis and genetic toxicology.

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E-Mail: info@akademie-fresenius.de
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