NAMs in Toxicological Assessments and Regulatory Perspective

Representatives from the regulatory authorities, the plant protection industry as well as from the scientific fields will be talking about New Approach Methodologies (NAMs) which is currently the most exciting topic in toxicological assessments.

08.05. — 09.05.2023
Online Conference
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During this online conference representatives from the regulatory authorities, the plant protection industry as well as from the scientific fields will be talking about New Approach Methodologies (NAMs) which is currently the most exciting topic in toxicological assessments.

Highlights

NAMs in general, recent publications including different examples for “Use of NAMs”

  • A framework for establishing scientific confidence in new approach methodologies
  • Transforming the evaluation of agrochemicals
  • Characterising local acute irritation properties of the fungicides Captan and Folpet with new approach methods
  • NAMs in endocrine disruption assessments
  • Quantitative in vitro and in vivo extrapolation (QIVIVE) for predicting reduced anogenital distance produced by anti-androgenic pesticides in a rodent model for male reproductive disorders
  • An analysis of the limitations and uncertainties of in vivo developmental neurotoxicity testing and assessment to identify the potential for alternative approaches

Work on NAMs

  • EFSA’s roadmap for NAMs, 4 real case studies
  • Case study NAMs and Tebufenpyrad – in a nutshell
  • Development of integrated approaches to testing and assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment
  • Development of AOPs for endocrine disruption properties
  • EFSA Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals – use of NAMs
  • Development of EFSA Guidance on Read-Across and implementation of NAMs

Who should attend this conference?

Professionals working in the fields of:

  • Toxicology
  • Registration
  • Marketing & distribution
  • Human exposure & risk assessment
  • Research & development
  • Product stewardship & responsible care
  • Human / consumer safety – crop protection

Sectors taking part:

  • Agrochemical industry
  • Research institutes
  • Authorities
  • Professional associations
  • Contract laboratories

Picture Credit: © apinan – AdobeStock

 

Programm

Monday, 8 May 2023 | 12:45 – 17:10

Timings are in Central European Summer Time CEST.

12:30
Login Time
12:45
Welcome address by Akademie Fresenius and introduction by the Chairs

Tamara Coja, Austrian Agency for Health and Food Safety (AGES), Austria
Susanne Hougaard Bennekou, Danish Patient Safety Authority, Denmark

NAMs in general, recent publications including different examples for “Use of NAMs”
A framework for establishing scientific confidence in new approach methodologies

Anna J. van der Zalm, PETA Science Consortium International, Germany

Characterising local acute irritation properties of the fungicides Captan and Folpet with new approach methods

Felix M. Kluxen, ADAMA Deutschland, Germany

Short break
NAMs in endocrine disruption assessments

Christiane Wiemann, BASF, Austria

Quantitative in vitro and in vivo extrapolation (QIVIVE) for predicting reduced anogenital distance produced by anti-androgenic pesticides in a rodent model for male reproductive disorders

Martin Scholze, Brunel University London, UK

Short break
An analysis of the limitations and uncertainties of in vivo developmental neurotoxicity testing and assessment to identify the potential for alternative approaches

Martin Paparella, Medical University of Innsbruck, Austria

Transforming the evaluation of agrochemicals

Douglas C. Wolf, Syngenta Crop Protection, USA



Tuesday, 9 May 2023 | 9:00 – 13:30

Timings are in Central European Summer Time CEST.

EFSA's work on NAMs
Overview of the EFSA NAMs case studies and the new NAMs4NANO project

Maria Chiara Astuto, European Food Safety Authority (EFSA), Italy

Case study NAMs and Tebufenpyrad – in a nutshell

Bertrand Desprez, ANSES, France

Short break
Development of integrated approaches to testing and assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment

Iris Mangas, EFSA Pesticide Peer Review (PREV) Unit, Italy

Development of AOPs for endocrine disruption properties
  • Scientific part
  • How an AOP is developed
  • Possible regulatory implications

Marina Marinovich, University of Milan, Italy

Short break
EFSA Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals – use of NAMs

Christer Hogstrand, King’s College London, UK (invited)

Development of EFSA Guidance on Read-Across and implementation of NAMs

Susanne Hougaard Bennekou, Danish Patient Safety Authority, Denmark

13:30
End of the online conference

Referent:innen

Folgende Referenten haben bereits zugesagt, weitere folgen in Kürze:

Name

Unternehmen

Astuto

Maria Chiara Astuto

European Food Safety Authority (EFSA), Italy

Maria Chiara Astuto is a Toxicologist and in her position as a Scientific Officer at EFSA, Methodology and Scientific Support (MESE) Unit, she is involved in the coordination of some outsourced activities aimed at promoting the implementation of NAMs in regulatory risk assessment, as well as in the coordination of the EFSA’s Scientific Committee cross-cutting Working Groups on Nanotechnologies and Genotoxicity.

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Bennekou

Susanne Hougaard Bennekou

Danish Patient Safety Authority, Denmark

Coja

Tamara Coja

Austrian Agency for Health and Food Safety (AGES), Austria

Tamara Coja is a Biologist and has been working as a Senior Regulatory Toxicologist at the Austrian Agency for Health and Food Safety (AGES) in Vienna. Since 2007 she has been involved in toxicological evaluation of pesticides. Her special regulatory interest is in toxicity of metabolites in residues of plant and animal origin and in groundwater. Since 2018 she is a member of the EFSA PPR Panel and joined working groups. She is also a member of the BfR Committee for Pesticides and their Residues.

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Bertrand Desprez

French Agency for Food, Environmental and Occupational Health and Safety (ANSES), France

Bertrand Desprez is the Deputy Head of the Toxicological Evaluation Unit of Pesticides (UETIV) in the Regulated Products Evaluation Directorate (RPD) at ANSES.

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Kluxen

Felix M. Kluxen

ADAMA Deutschland, Germany

Felix M. Kluxen is a Pharmacist and Certified Toxicologist and has been a Regulatory Toxicologist for ADAMA since 2016. His main interests are NAMs, statistics in toxicology and risk assessment. He is a member of several CropLife Europe teams and international project groups.

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Iris Mangas

European Food Safety Authority (EFSA), Italy

Iris Mangas is a Regulatory Toxicologist. She holds a Ph D in molecular toxicology. Since 2018, she is a Scientific Officer at EFSA. She is currently in charge of the Peer Review of Pesticides Risk Assessment and supports the developmental activities for improving EFSA Risk assessment methods in the area of developmental neurotoxicity and Endocrine Disruptor properties, including development of IATA case studies and AOPs.

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Marina Marinovich

University of Milan, Italy

Marina Marinovich is a Full Professor of Toxicology in the Department of Pharmacology and Biomolecular Sciences (DiSFeB) of the Section of Toxicology and Risk Assessment at the University of Milan. She has been a member of EFSA’s PPR Panel since 2018 and for the last two years she has been the Chair of the Working Group on AOP.

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Paparella

Martin Paparella

Medical University of Innsbruck, Austria

Martin Paparella has studied food- and biotechnology as well as toxicology. Currently he is a Senior Researcher in the field of regulatory toxicology at the Institute of Medical Biochemistry of the Medical University of Innsbruck in Austria. Martin aims to bridge science with the regulation of chemicals and is contributing to the development and standardization of non-animal-methods based approaches for regulatory toxicology within several related expert working groups for the OECD and EFSA. Martin also contributes to European research projects such as the European Partnership for the Assessment of Risk from Chemicals (PARC) and the European Horizon 2020 project ALTERNATIVE and national activities like the Austrian Green Chemistry Platform.

mehrweniger

Martin Scholze

Brunel University London, UK

Christiane Wiemann

BASF, Austria

Wolf

Douglas C. Wolf

Syngenta Crop Protection, USA

Douglas C. Wolf graduated in 1981 from the University of Missouri with a Doctor of Veterinary Medicine degree (D.V.M.) and, after 6 years in clinical veterinary practice, attended Purdue University where, in 1991, he completed a residency in pathology and Ph.D. in Veterinary Pathology. Douglas was a staff scientist for 6 years at the Chemical Industry Institute of Toxicology (CIIT) where he studied chemical carcinogenesis. From 1997 until 2013 Douglas held various research and leadership positions with the U.S. Environmental Protection Agency, where he continued research in chemical carcinogenesis and molecular pathology. In 2013 he joined Syngenta Crop Protection and is currently a Senior Syngenta Fellow where he leads international efforts to advance the science of risk assessment focusing on crop protection chemicals. Douglas has authored or coauthored over 155 journal articles, book chapters, and technical reports and is a Fellow of the International Academy of Toxicologic Pathologists and the Academy of Toxicological Sciences.

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van der Zalm

Anna J. van der Zalm

PETA Science Consortium International, Germany

Anna J. van der Zalm is an Advisor to PETA Science Consortium International. She received her MChem (Master’s degree) in Chemistry from the University of Oxford, and gained experience in regulatory affairs prior to joining the Consortium in 2018, where she now focuses on the development and implementation of reliable and relevant non-animal approaches.

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