International Akademie Fresenius Conference "Regulatory Toxicology of Active Substances in Plant Protection Products"

2 Dec - 3 Dec 2019, Atrium Hotel Mainz/Germany

International Akademie Fresenius Conference "Regulatory Toxicology of Active Substances in Plant Protection Products"

Overview Programme Speakers Venue Prices & Services

Overview

Highlights

In vitro comparative metabolism studies

  • Report from the EFSA Workshop: Data requirement, human relevance of animal data

EFSA future developments

  • Development of adverse outcome pathways (AOP)
  • In vitro screening battery

Cumulative assessment and combined exposure

  • Cumulative assessment groups and tools used to draft scientific reports
  • Dietary and non-dietary combined risk assessment

QSAR and read-across

  • Assessment of genotoxicity and general toxicity of metabolites in residues
  • Use of in silico tools

Genotoxicity of active substances

  • Hurdles and challenges
  • In vivo comet assay

Impurities

  • Impurity profiles of active substance

Evaluation of public literature

  • Relevance and reliability
  • SciRAP tool

Benchmark dose modelling

  • Current state of the approach
  • Regulatory use

Who do you meet?

Groups that should take part:

Managing directors, boards of directors, members of supervisory boards, managers and scientists in the field of:

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

Sectors that should take part:

  • Agrochemical industry
  • Research institutes, authorities (agricultural inspection offices, registration and control authorities)
  • Professional associations
  • Contract laboratories

Picture credit: © noerenberg

Programme

Get-Together on Sunday, 1 December 2019
Will you arrive on Sunday? Come to the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.

Monday, 2 December 2019

9.00 Registration and coffee and tea
9.30 Welcome address by Akademie Fresenius and the Chair
Tamara Coja
, Austrian Agency for Health and Food Safety (AGES), Austria

Metabolism studies

9.40 Report from the 2018 EFSA Workshop „In vitro comparative metabolism studies in regulatory pesticide risk assessment“: Data requirement in vitro comparative metabolism study

  • Minimum amount of information to be included in the study protocols and provided
  • Key elements to be considered for the interpretation of the study‘s outcome

Emanuela Testai, Italian National Institute of Health (ISS), Italy

10.05 In vitro comparative metabolism studies in regulatory pesticide risk assessment: Human relevance of animal data

  • Assessment of the potential for thyroid disruption for human health and investigation whether liver enzyme induction is responsible for thyroid disruption
  • Key elements to be measured to evaluate the liver enzyme induction-mediated thyroid disruption

Alfonso Lostia, European Food Safety Authority (EFSA), Italy

10.30 Panel discussion

10.50 Coffee and tea break

Cumulative assessment

11.20 Cumulative assessment groups from a toxicological point of view – example: “Establishment of cumulative assessment groups of pesticides for their effects on the nervous system/thyroid” – tools used to draft scientific reports, e.g. basic principles of

  • Scientific Opinion on the guidance on the use of the weight of evidence (WoE) approach in scientific assessments
  • Guidance on expert knowledge elicitation in food and feed safety risk assessment

Susanne Hougaard Bennekou, Danish Technical University (DTU), Denmark

11.45 What can we take from cumulative assessment groups (CAG) for dietary and non-dietary combined risk assessment?

  • Basis of CAGs and their validity
  • Application to dietary and non-dietary combined risk assessment

Susy Brescia, Health and Safety Executive, Chemicals Regulation Division (HSE CRD), UK

12.10 Panel discussion

12.30 Lunch

Evaluation of public literature

13.30 Assessment of public literature – how to appropriately decide upon relevance and reliability?

Johanna Kaltenhäuser, German Federal Institute for Risk Assessment (BfR), Germany

13.55 Systematic evaluation of in vitro and in vivo data for health risk assessment of chemicals – the SciRAP tool

  • Evaluation of data for health risk assessment and movement towards systematic review methodology in health risk assessment – advantages and challenges
  • The SciRAP initiative and tool

Anna Beronius, Karolinska Institute, Sweden

14.20 Panel discussion

14.40 Coffee and tea break

Benchmark dose modelling

15.10 The benchmark dose (BMD) approach: Basic principles and recent developments

  • Deriving a point of departure for risk assessment
  • Incorporating all model results by model averaging

Bas Bokkers, National Institute for Public Health and the Environment (RIVM), The Netherlands

15.35 Overcoming hurdles in regulatory use of the BMD concept

Susanne Rudzok, German Federal Institute for Risk Assessment (BfR), Germany

16.00 Panel discussion

16.20 Short break

Substance evaluation

16.35 Genotoxicity and active substance evaluation: Hurdles and challenges, some examples and obstacles

  • Member State perspective

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

17.00 Genotoxicity and active substance evaluation: Applicability of follow-up in vivo tests, especially in vivo comet assay

  • Overview of positive in vitro data
  • Appropriate in vivo follow up

Damian Bowen, ERM – Environmental Resources Management, UK

17.25 Panel discussion

17.45 End of the first conference day

18.30 Departure time for the evening event
After the first conference day Akademie Fresenius would like to invite you to a leisurely evening at the vineyard of Joachim Flick in the wine-growing region Rheingau. You have the opportunity of better getting to know other participants you met during the day over a relaxed wine tasting and meal. Don’t miss out on this opportunity!

Tuesday, 3 December 2019

8.30 Welcoming speech by the Chair
Susanne Hougaard Bennekou,
Danish Technical University (DTU), Denmark

QSAR and read-across

8.40 In silico prediction of the toxicity and genotoxicity of metabolites in residues

  • Application of QSAR to predict the toxicity of metabolites and read-across of data from the parent substance to the metabolite
  • Methods to assess uncertainties in predictions of toxicity

Mark Cronin, Liverpool John Moores University, UK

9.05 Use of QSAR and read-across for assessment of genotoxicity and general toxicity of metabolites in residues of plant and animal origin – how far we are and how certain do we want to be? Industry perspective

  • Chemical descriptors, applicability domain, chemical similarity, data quality and ownership
  • Training of QSAR models, read-across and weight of evidence for higher tier evaluation

Markus Frericks, BASF, Germany

9.30 Read-across and metabolites: A few thoughts from a regulator and an example

  • When does a “grouping concept“ make sense and when it does not?
  • Difficulties in identification of a “lead molecule“ for potential toxicity testing

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

9.55 Panel discussion

10.25 Coffee and tea break

10.55 Use of in silico tools for prediction of genotoxicity of pesticides and their metabolites – results from a recent EFSA project related to use of in silico methods for prediction of genotoxicity of pesticides and their metabolites

  • Main findings, main conclusions and recommendations

Rositsa Serafimova, European Food Safety Authority (EFSA), Italy

11.25 Questions & answers

Impurities

11.35 The impurity profile of an active substance – assessment of the toxicological relevance of the impurities: Hurdles and challenges – Member State perspective

  • Assessment of the reference source specifications during the renewal of active substance approval
  • Toxicological relevant impurities

Agathi Charistou, Benaki Phytopathological Institute, Greece

12.00 Panel discussion

12.15 Lunch

EFSA future developments

13.45 Current developments on EFSA level: Projects, ongoing activities, outputs

Manuela Tiramani, European Food Safety Authority (EFSA), Italy
14.15 Questions & answers

14.25 Application of AOPs to address biological plausibility of associations observed in epidemiological studies for pesticides

  • Assessing mechanistic knowledge to support regulatory application in adverse outcome pathway (AOP) descriptions
  • Systematic consideration of the extent of supporting mechanistic data for regulatory application

Bette Meek, University of Ottawa, Canada

14.50 An in vitro screening battery for developmental neurotoxicity evaluation: Past and current scientific and regulatory activities

Ellen Fritsche, IUF – Leibniz Research Institute for Environmental Medicine, Germany

15.15 Panel discussion

15.40 End of the conference


Speakers

Name

Company

Beronius

Anna Beronius

Karolinska Institute, Sweden

Anna Beronius is an Assistant Professor and a Lecturer at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm. Her research focuses on structured methods for evidence evaluation and integration in health risk assessment of chemicals. Her main interest is the hazard and risk assessment of endocrine disruptors and chemical mixtures. She is one of the initiators and developers of the Science in Risk Assessment and Policy (SciRAP) web-based platform. Dr Beronius is also involved in various expert assignments to support national and international agencies and organisations in the area of hazard and risk assessment. She is involved in organizing courses in health risk assessment, for example at Karolinska Institutet and at the European Food Safety Authority.

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Bokkers

Bas Bokkers

RIVM - National Institute for Public Health and the Environment, The Netherlands

Bas Bokkers is a Modeller and European Certified Toxicologist and has been working at the Dutch National Institute for Public Health and the Environment (RIVM) since 2017, currently at the RIVM Centre for Safety of Substances and Products. His work primarily concerns benchmark dose (BMD) modelling, kinetic modelling of chemicals and probabilistic risk assessment, including exposure assessment. Bas teaches BMD courses on a regular basis and will present the current practices of the BMD approach.

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Bowen

Damian Bowen

ERM - Environmental Resources Management, UK

Damian Bowen is a Mammalian Toxicologist working for ERM for over 9 years within the regulatory services group. He has spent time within the contract research organisation arena working as a Genetic Toxicology Study Director. This involved running the full remit of cell based and animal genotoxicity studies including the comet assay, with papers that have been written and referenced globally.

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Brescia

Susy Brescia

Health and Safety Executive, Chemicals Regulation Divison (HSE CRD), UK

Susy Brescia works as a Regulatory Toxicologist at the UK HSE / CRD and has many years of experience in the risk assessment of pesticides, biocides and industrial chemicals. Susy has relevant expertise on mixture toxicity and has been involved in the public consultation of the EFSA guidance documents on CAGs.

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Charistou

Agathi Charistou

Benaki Phytopathological Institute, Greece

Agathi Charistou is a Regulatory Toxicologist in the Laboratory of Toxicological Control of Pesticides at the Benaki Phytopathological Institute in Greece with long experience in the evaluation of mammalian toxicology studies and non-dietary exposure assessment to both plant protection products and biocides.

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Coja

Tamara Coja

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

Tamara Coja is a Biologist and has been working as a Regulatory Toxicologist and Senior Expert at the Austrian Agency for Health and Food Safety (AGES) in Vienna, Division for Plant Protection Products, Department of Toxicology since 2007. She is involved in toxicological risk assessment of plant protection products including risk assessment for operator, bystander and worker in context of plant protection products, the evaluation of active substances and plant protection products with respect to toxicology as well as classification and labelling. 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.

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Mark Cronin

Liverpool John Moores University, UK

Mark Cronin is a Professor of Predictive Toxicology at Liverpool John Moores University, England. He has been working in the area of computational toxicology for over 30 years to predict both the human health and environmental effects of chemicals.

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Frericks

Markus Frericks

BASF, Germany

Markus Frericks is a Biologist and a European Registered Toxicologist and works as a Regulatory Toxicologist at BASF in Mannheim. He is the Vice Chair of the Working Group on Computational Toxicology from the German Society of Toxicology (GT) and the Chair of the ECPA Working Group on Genotoxicity-QSAR.

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Fritsche

Ellen Fritsche

IUF - Leibniz Research Institute for Environmental Medicine, Germany

Ellen Fritsche is habilitated for Environmental Toxicology and is appointed as a full Professor by the Heinrich-Heine-University in Dusseldorf. She holds a Group Leader position at the IUF - Leibniz Research Institute for Environmental Medicine. Moreover, she is a Project Leader of CERST-NRW (Center for Alternatives to Animal Testing – NRW), is involved in the generation of Adverse Outcome Pathways (AOP) and member of the OECD expert group for producing a guidance document for alternative DNT testing.

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Hougaard Bennekou

Susanne Hougaard Bennekou

DTU Food - National Food Institute, Denmark

Susanne Hougaard Bennekou joined the Division of Risk Assessment and Nutrition at the National Food Institute of the Technical University of Denmark (DTU) as a Senior Advisor in toxicology in January. She has previously worked as a Senior Advisor in the Pesticide Division of the Danish EPA. She was the Vice-Chair of the EFSA PPR panel and since last year she has been a Vice-Chair of the EFSA Scientific Committee.

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Johanna Kaltenhäuser

German Federal Institute for Risk Assessment, Germany

Johanna Kaltenhäuser has been working in the Unit “Steering and Overall Assessment“ in the Pesticides Safety Department of the German Federal Institute for Risk Assessment.

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Kneuer

Carsten Kneuer

German Federal Institute for Risk Assessment, 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. He started working for the BfR in 2007 as a Senior Scientist Risk Assessment.

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Lostia

Alfonso Lostia

European Food Safety Authority (EFSA), Italy

Alfonso Lostia is a Biochemist and joined EFSA in 2018 where he works in the Pesticide Unit on the pesticide risk assessment. Before joining EFSA, he has worked for almost 6 years at the Joint Research Centre in the Unit of Chemical Safety in the area of predictive toxicology. He has worked on several projects focused on advancing the regulatory acceptance of non-animal toxicity testing methods and he focused his expertise on Endocrine Disruptors and in vitro Toxicokinetics.

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Meek

Bette Meek

University of Ottawa, Canada

Bette Meek is the Associate Director of Chemical Risk Assessment at the McLaughlin Centre for Risk Science, Faculty of Medicine, University of Ottawa. She has managed chemical risk assessment programmes within Health Canada and contributed to or led initiatives in developing methodology in chemical risk assessment, most recently as a member of the OECD Expert Advisory Group on Molecular Screening and Toxicogenomics (EAGMST).

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Susanne Rudzok

German Federal Institute for Risk Assessment, Germany

Susanne Rudzok is a Biochemist and a Toxicologist and has been working as a Scientific Officer in the Unit “Toxicology of Active Substances and their Metabolites” in the Pesticides Safety Department of the German Federal Institute for Risk Assessment.

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Rositsa Serafimova

European Food Safety Authority (EFSA), Italy

Rositsa Serafimova has been working as a Scientific Officer in European Food Safety Authority (EFSA) since September 2012, first in Food ingredients and packaging Unit and currently in Pesticides Peer Review Unit. Before joining EFSA she worked at the European Commission Joint Research Centre and at the Laboratory of Mathematical Chemistry, Burgas University (Bulgaria) as a Researcher. A substantial part of her research has focused on development, assessment and application of computational methods for prediction of mammalian toxicity in the context of chemical risk assessment.

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Testai

Emanuela Testai

Italian National Institute of Health (ISS), Italy

Emanuela Testai is a Toxicologist in the Environment and Health Department at the ISS, the Italian National Institute of Health. Her expertise is focused on mammalian toxicology, alternative methods, toxicokinetics and risk assessment, dealing with research and regulatory activities as well. She is active in several scientific committees (e.g. WHO, EU DG-SANTE non food SC, EFSA, JRC-Eurl-ECVAM).

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Manuela Tiramani

European Food Safety Authority (EFSA), Italy

Manuela Tiramani has been working as the Head of the Pesticide Peer Review Unit in the Department of Scientific Evaluation of Regulated Products at EFSA since this year. She joined EFSA in 2005 as a Scientific Officer in the Pesticide Unit and became Head of the FEED Unit in 2015.

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Venue

Atrium Hotel Mainz
Flugplatzstr. 44
55126 Mainz
Phone: +49 6131 491-0
E-Mail: infoatrium-mainz.de
www.atrium-mainz.de

We have reserved a limited number of rooms for our participants at reduced rates at the hotel. These rooms can be booked up to 6 weeks prior to the start of the event. Please book early and directly through the hotel quoting „Akademie Fresenius“ as reference.

Prices & Services

Participation Fee: € 1,895.00 plus VAT.

The registration fee includes the following benefits:

  • conference participation
  • conference documentation
  • lunch
  • coffee breaks and conference beverages
  • the evening event on 2 December 2019

Representatives of an authority or a public university are therefore eligible for a reduced fee of € 795.00 plus VAT per person (please provide evidence). The reduced fee cannot be combined with other rebates.

Group reductions

For joint bookings received from one company we grant a 15 % discount from the third participant onwards (it doesn’t apply for representatives of an authority or a public university).


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Event Documentation

Would you like to attend but cannot spare the time?

Although we cannot substitute an intensive exchange with your fellow colleagues, we can provide you with a complete set of event documentation. The event documentation package includes all the presentations on the event agenda (subject to the approval of our speakers). It will be sent out around two weeks after the event once we have received your payment (free of shipping costs). We will also provide you with details on how to access the restricted download section on our website. This section contains all the latest versions of the presentations in colour and in digital form.

Price: € 295.00 plus VAT


Order event documentation
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Sabine Mummenbrauer

Your Contact

Sabine Mummenbrauer
Programme and conceptual design

+49 231 75896-82
smummenbrauerakademie-fresenius.de

Sabine Mummenbrauer

Your Contact

Sabine Mummenbrauer
Programme and conceptual design

+49 231 75896-82
smummenbrauerakademie-fresenius.de

Sabine Mummenbrauer

Your Contact

Sabine Mummenbrauer
Programme and conceptual design

+49 231 75896-82
smummenbrauerakademie-fresenius.de

Danielle Sörries

Your Contact

Danielle Sörries
Organisation and participant management

+49 231 75896-74
dsoerriesakademie-fresenius.de

Danielle Sörries

Your Contact

Danielle Sörries
Organisation and participant management

+49 231 75896-74
dsoerriesakademie-fresenius.de

How to become an exhibitor

Our event offers you the opportunity of presenting your company in a special exhibition.

You can personally present your products and services directly to your specific target group. We would be happy to provide you with further information on all the available options from a simple product information display to a complete exhibition stand.

We would be pleased to assist you personally:

Dominique Perry

Dominique Perry
Phone: +49 231 75896-64
dperryakademie-fresenius.de

Press contact

We offer journalists and editors a platform where they can get in touch with the experts.

If you are the editor of a specialist publication and interested in a press pass or media partnership, please contact us well in advance. We would be pleased to send you our press bulletin as well as photographic materials where available as soon as the event is over.

Please contact us:

Rebecca Keuters

Rebecca Keuters
Phone: +49 231 75896-76
rkeutersakademie-fresenius.de