10th International Akademie Fresenius Conference "Endocrine Disruptors"

12.11. - 13.11.2019, Leonardo Royal Hotel Frankfurt/Germany

10th International Akademie Fresenius Conference "Endocrine Disruptors"

Übersicht Programm Referenten Veranstaltungsort Preise & Leistungen

Übersicht

Highlights

Regulation on Biocides and Pesticides in Europe

  • Latest updates from the EU Commission and the ECHA ED Expert Group
  • Implementation of the ED criteria: Member State, industry and NGO view
  • Practical experiences and recommendations for applicants

Endocrine Testing in Aquatic Vertebrates

  • Overview on test methods: FSTRT, MEOGRT and LAGDA
  • Effects of thyroid disruption in fish including AOPs

Human Health Aspects

  • U.S. EPA on predictions of endocrine
  • hazard and risk based on ToxCast
  • ED assessment from a human health perspective – actual vs target conditions

Pharmaceuticals

  • ED properties assessment for drug actives

Communication and Monitoring

  • Understanding the challenges of communicating the risks of endocrine
    disrupting chemicals and a way towards more transparency
  • Water quality management in the Netherlands and innovative monitoring
    approaches 

Who do you meet?

Professionals working in the fields of:

  • Toxicology and ecotoxicology
  • Chemical risk assessment
  • Research and development
  • Regulatory affairs
  • Registration and authorisation
  • Legal and general counselling

Sectors taking part:

  • Chemical/biocide/agrochemical/pharmaceutical/cosmetic industries 
  • Research institutes
  • Regulatory authorities
  • Environmental and health risk consultants
  • Testing laboratories and contract research organisations (CROs)
  • NGOs

Picture credit: @Subbotina Anna/shutterstock.com, @chestra - Fotolia.com

Programm

Get-together on Monday, 11 November 2019

Will you arrive on Monday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.

Tuesday, 12 November 2019

8.30 Registration and coffee
9.00 Welcome address by Akademie Fresenius and introduction by the Chair
Lennart Weltje
, BASF, Germany

Regulation on Biocides and Pesticides in Europe

9.10 Criteria for ED identification under EU Regulations on plant protection products and on biocidal products – implementation and current status

  • The European Commission strategy for ED
  • Application of the guideline
  • Next steps and future perspective

Maristella Rubbiani, European Commission, DG SANTE,Belgium

9.35 Member State view on the implementation of the criteria for endocrine disruptors

Emily McVey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

10.00 Implementation of ED criteria in the ECHA ED Expert Group

  • Rigid application of the guidance or weight of evidence
  • ECHA vs EFSA similar approaches?
  • REACH and future prospects

Alan Breen, Department of Agriculture, Food and the Marine, Ireland

10.25 Coffee break

10.55 Effective regulation of endocrine disruptors? A critical view after one year of implementation

  • Implementation of ED criteria in EU legislation
  • Priorities for improving and speeding up ED regulation
  • Beyond pesticide & biocide policy – the need for a robust and comprehensive EU EDC action plan

Susanne Smolka, Pesticide Action Network (PAN) Germany

11.20 Implementation of the new criteria for endocrine disruptors – industry view

  • Learning from experience
  • Weighing the evidence – the heart of the matter
  • Communication and transparency
  • Future prospects and implications for other chemical sectors

Andrew Adams, ECPA ED Expert Group, France

11.45 Practical experiences with the implementation of the ED guidance

  • Requirements, challenges and first experiences
  • ED assessment of actives and biocidal products, co-formulant screening approach
  • Testing vs non-testing – what is “sufficiently investigated”?
  • Practical implications and regulatory consequences
  • Recommendations for applicants

Martina Duft, knoell Germany

12.10 Panel discussion

13.00 Lunch

Endocrine Testing in Aquatic Vertebrates

14.30 The Fish Short Term Reproduction Test (FSTRT): performance, interpretation and limitations

  • The FSTRT as a key assay for the detection of estrogen, androgen and steroidogenic activity
  • Analysis of a historical control database of 49 studies
  • Elements of test design and interpretation in context with the historical data

James Wheeler, Shell International, The Netherlands

14.55 Effects of thyroid disruption in fish

  • Central and peripheral control of thyroid hormones
  • Effects of thyroid disruption in fish including AOPs
  • Testing and identification of thyroid disruptors

ZhiChao Dang, National Institute for Public Health and the Environment (RIVM), The Netherlands

15.20 Coffee break

15.50 Experiences in conducting amphibian assays

  • Insight into practical experiences in conducting tests on Xenopus laevis
  • Limits and possibilities for each test design

Melanie Lichtenberger, ibacon, Germany

16.15 Conducting MEOGRT and LAGDA: challenges and 3Rs implications

  • Why consider the 3Rs?
  • Implications of conducting MEOGRT and LAGDA on animal use
  • Addressing the challenges

Natalie Burden, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), United Kingdom

16.40 Panel discussion

17.10 End of first day

18.15 Departure time for the evening event
At the end of the first conference day Akademie Fresenius invites you to a leisurely evening at the restaurant “Daheim im Lorsbacher Thal” in Frankfurt. You have the opportunity of better getting to know other participants you met during the day over a relaxed meal. Don’t miss out on this opportunity!

Wednesday, 13 November 2019

8.30 Welcome address by the Chair Emily McVey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

Human Health Aspects

8.40 An update on public tools for prediction of endocrine hazard and risk

  • Assessment of available in silico and in vitro data and predictions based on ToxCast
  • Use of high-throughput toxicokinetic data and models
  • Endocrine bioactivity exposure ratio (BER)

Katie Paul Friedman, U.S. Environmental Protection Agency (EPA), United States of America

9.05 ED assessment from a human health perspective – actual vs target conditions

  • Requirements of the ECHA/EFSA ED guidance document
  • Update of information requirements using biocides as an example
  • Tiered testing strategies: another “mega mouse study“ vs animal welfare?
  • Considerations on mode of action and AOPs

Michael Werner, Consultant, Germany

9.30 The real causes for the risen trends in endocrine related diseases

  • Overview on increased diseases and health parameters
  • Endocrine disruption theory
  • Impact of changes in human reproduction

Gerard Swaen, Maastricht University, The Netherlands

9.55 Coffee break

Risk Communication

10.25 The challenges of communicating about riskin relation to (environmental) endocrine disrupting substances

  • Who communicates to/with whom in the science – policy – public interface and how?
  • Conflicting views among endocrine disruptor experts: a major challenge to effective stakeholder communication
  • Working towards more transparency for the benefit of better communication

Annegaaike Leopold, Calidris Environment, The Netherlands

10.50 Panel discussion

Pharmaceuticals

11.20 Environmental impact of active pharmaceutical ingredients (API) and their ED properties

  • Pharmaceuticals in the environment (PIE): a matter of concern
  • Environmental risk assessment (ERA) of active pharmaceutical ingredients: the scientific approach
  • European Medicines Agency (EMA) guidance 2006 and its ongoing revision
  • ED properties assessment for drug actives

Antonio Conto, Chemsafe, Italy

11.45 Short break

Monitoring

12.00 Contaminants of emerging concern in the watercycle

  • Water quality management in the Netherlands
  • Risk-based monitoring and innovative monitoring approaches
  • Bioassays for water quality

Milou Dingemans, KWR Water Research Institute,The Netherlands

Outlook on new Research Projects

12.25 New EU Horizon 2020 ED projects: GOLIATH and the EURION Cluster

  • Overview and objectives of the EURION Cluster
  • The GOLIATH project
  • First research outcomes

Daniel Zalko, French National Institute for Agricultural Research (INRA), France

12.50 Panel discussion

13.20 Lunch and end of the conference

Referenten

 

 

Name

Unternehmen

Adams

Andrew Adams

ECPA ED Expert Group, France

Andrew Adams has many years of experience working in European regulatory affairs for biocides and moved into a public and governmental affairs role at Bayer CropScience in 2014 where he is now the Global Issues Lead for Insecticides and Fungicides. With specific focus on endocrine disruptors, he currently represents Crop Life International and the ECPA as Chair of their ED Expert Groups.

mehrweniger
Breen

Alan Breen

Department of Agriculture, Food and the Marine, Ireland

Alan Breen is a Regulatory Toxicologist working with the Department of Agriculture, Food and the Marine of Ireland. He has 25 years of experience in the area of chemical safety evaluation and risk assessment and is also a member of the ECHA ED Expert Group.

mehrweniger
Burden

Natalie Burden

National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), United Kingdom

Natalie Burden has led a programme of work at the NC3Rs dedicated to advancing the application of the 3Rs in toxicology and regulatory sciences since 2014. She leads projects supported by expert working groups across industry, academia and governmental/regulatory agencies to support changes in policy and practice and identify opportunities within regulatory frameworks to reduce, refine and replace animal use.

mehrweniger
Conto

Antonio Conto

Chemsafe, Italy

Antonio Conto is a European Registered Toxicologist and the founder of Chemsafe. He has over 28 years of post-graduate experience, mainly in risk assessment and regulatory toxicology for chemical and pharmaceutical companies. Nowadays, his role is mainly focused on managing Chemsafe and reviewing toxicology/safety expert reports. Prior to founding Chemsafe, he worked as a Study Director and Head of the C&L Unit at RBM SpA (now Merck-Serono). He is member of CHCS (Chemical Hazard Communication Society), SETAC Europe (Society of Environmental Toxicology and Chemistry), ACS (American Chemical Society), SITOX (Italian Society of Toxicology) and SOT (US Society of Toxicology).

mehrweniger
Dang

ZhiChao Dang

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

ZhiChao Dang is an EU Registered Toxicologist and works as a Senior Risk Assessor and Project Leader at RIVM. He has been involved in risk assessments of EU existing and new substances, the OECD HPV substances and the WHO substances as well as the work on setting environmental quality standards. He has been working on REACH testing proposals, risk management options, the preparation of various dossiers for ECHA and has been involved in the development of EU and OECD documents on endocrine disruptors as well as the development of OECD test guidelines. He is also working on the environmental risk assessment of pharmaceuticals and related methodology development. He is member in several OECD and EU expert groups, including the OECD EDTA AG, the OECD VMG Eco, the OECD VMG NA and the EU ED EAG.

mehrweniger
Dingemans

Milou Dingemans

KWR Watercycle Research Institute, The Netherlands

Milou Dingemans has over 15 years of experience in scientific research on the harmful effects of the exposure to chemicals on health and has been a Researcher and Toxicologist in the Chemical Water Quality and Health Team at KWR Watercycle Research Institute since 2016. She works on the assessment of possible health hazards of substances relevant to the water cycle (such as environmental contaminants) on commissions from water utilities, government and industry and is also active in the development, validation and implementation of innovative test methods (such as bioassays) and risk assessment techniques related to chemical water quality.

mehrweniger
Duft

Martina Duft

knoell Germany

Martina Duft is a Senior Expert Regulatory Ecotoxicologist at knoell Germany and is the coordinator of the knoell ED expert team and key contact for the topic endocrine disruptors. After several years in ED related research, she has worked for over 15 years in various regulatory sectors with a focus on ecotoxicology an regulatory affairs.

mehrweniger
Leopold

Annegaaike Leopold

Calidris Environment, The Netherlands

Annegaaike Leopold is a Biologist by training and has 30 years of experience in the applied regulatory ecotoxicology field. She has contributed to environmental endocrine disruptor test guidelines and has worked on hazard and risk assessment of endocrine disruptors in the contract laboratory context both in research and guideline development as well as in business development and project management. She currently has her own consultancy firm working both on environmental endocrine regulatory projects and doing research in the area for science for policy - focusing on contributing to greater transparency in scientific processes to help society (regulators, policy-makers, scientists, concerned citizens) grapple with the different types of uncertainties built into the regulatory system of chemicals assessment.

mehrweniger
Lichtenberger

Melanie Lichtenberger

ibacon, Germany

Melanie Lichtenberger holds a PhD in biology with a focus on ecotoxicology. During her PhD and work as a Study Director in aquatic ecotoxicology she was involved in conducting endocrine studies in the lab. Currently she works at ibacon as Head of Test Facility and is also involved in the hazard identification of endocrine disruptors.

mehrweniger
McVey

Emily McVey

Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

Emily McVey is an experienced Regulatory Toxicologist and works as a Risk Assessor in ecotoxicology at the Ctgb. Her specialties include environmental toxicology, wild vertebrates (birds, mammals, amphibians, fish), molecular mechanisms of toxicity, neurodevelopmental toxicity and endocrine disruption testing and assessment.

mehrweniger
Paul Friedman

Katie Paul Friedman

U.S. Environmental Protection Agency (EPA), United States of America

Katie Paul Friedman joined the National Center for Computational Toxicology in the Office of Research and Development at the US EPA in August 2016, where she is currently focused on integration of multiple information streams to address the needs of preliminary risk assessment, with additional interests in uncertainty in alternative and traditional toxicity information, endocrine bioactivity prediction and in vitro kinetics. Previously, she worked as a Regulatory Toxicologist at Bayer CropScience with specialties in neurodevelopmental and endocrine toxicity, high-throughput science, and predictive toxicology. She has been actively involved in multi-stakeholder projects to develop adverse outcome pathways, alternative testing approaches, and the regulatory acceptance of these tools.

mehrweniger
Rubbiani

Maristella Rubbiani

European Commission, Belgium

Maristella Rubbiani is Policy Officer at the European Commission and in charge of ED issues and coformulants. Previously, she worked at the Italian Competent Authority where she was responsible for the implementation of the regulation for biocides and PPPs.

mehrweniger
Smolka

Susanne Smolka

Pesticide Action Network (PAN) Germany

Susanne Smolka is an Ecotoxicologist and works as Senior Policy Advisor for the German Pesticide Action Network (PAN Germany). She accompanied the revision and implementation of the EU pesticide and biocide legislation over the past 17 years with the main focus on improving the regulation of substances of high concern such as endocrine disruptors. She is an expert in non-chemical pest management and represents PAN Germany in various national and European forums. Prior to her engagement with PAN she worked for WWF Germany and other environmental NGOs.

mehrweniger
Swaen

Gerard M. H. Swaen

Maastricht University, The Netherlands

Gerard Swaen is an Associate Professor at Maastricht University and an Occupational Epidemiologist with a specific interest in the potential health effects from exposure to chemicals. He has conducted epidemiology studies on chemicals such as acrylonitrile, carbon disulphide, coal tar, coke factories.

mehrweniger
Weltje

Lennart Weltje

BASF, Germany

Lennart Weltje holds a PhD in ecotoxicology and environmental chemistry and currently works as a Senior Ecotoxicologist at BASF conducting risk assessments for PPPs and biocides. His former stations include the Dutch National Institute for Public Health and the Environment (RIVM).

mehrweniger
Werner

Michael Werner

Consultant, Germany

Michael Werner is a Chemist and Eurotox registered Toxicologist with an over 20 years track record in hazard, exposure and risk assessments in various regulatory areas including classification and labelling. In his present role as a Senior Expert Regulatory Toxicology Biocides and Assistant to the Managing Director, he leads a small biocides group and provides regulatory as well as scientific/technical advice to clients for the preparation of biocidal active substance/product dossiers. Another focus of his work is the development of tailor-made dossier strategies for the authorisation of biocidal products/product families in their various and sometimes non-standard applications including animal safety and dietary risk assessment of biocides.

mehrweniger
Wheeler

James Wheeler

Shell International, The Netherlands

James Wheeler works as an Ecotoxicologist for Shell International. His work focuses on environmental risk assessment and ecotoxicology testing. He has a particular interest in fish endocrine test methods and is a member of several industry and OECD work groups active in this area.

mehrweniger
Zalko

Daniel Zalko

French National Institute for Agricultural Research (INRA), France

Daniel Zalko is a Research Director at the French National Institute for Agricultural Research (INRA) and heads the “Metabolism and Xenobiotics” team of the TOXALIM research center in food toxicology. His research focuses on the metabolism of food and environmental contaminants, with an emphasis on the relationship between specific bioactivation pathways and adverse toxicological outcomes. A large part of this work is focused on EDCs.

mehrweniger

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