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DIE AKADEMIE FRESENIUS Where Experts Meet!
The Experts
Niklas Andersson European Chemicals Agency (ECHA) | Domenica Auteri European Food Safety Authority (EFSA) | Lisa Baumann University of Heidelberg | Alan Breen Irish Department of Agriculture, Food and the Marine | Jean-Pierre Busnardo Corteva Agriscience | Elke Eilebrecht Fraunhofer Institute for Molecular Biology and Applied Ecology IME | Taisen Iguchi Japanese National Institute for Basic Biology | Laurent Lagadic Bayer | Mark Lohmann German Federal Institute for Risk Assessment (BfR) | Stefania Lymperi Aristotle University of Thessaloniki | Kamel Mansouri ILS/U.S. National Institute of Environmental Health Sciences (NIEHS) | Peter Matthiessen Independent Consultant | Emily McVey Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) | Stephanie Melching-Kollmuss BASF | Ninja Reineke CHEM Trust | Lennart Weltje BASF | James Wheeler Corteva Agriscience
And: Representative of the European Commission’s DG SANTE
Highlights
Regulatory Developments
• Update from the European Commission’s DG SANTE on the new criteria for ED identification under EU Regulations on plant protection and biocidal products
• Overview from ECHA and EFSA’s Pesticides Unit on implementing the new ED guidance document with regard to plant protection products and biocides
• Implementation of the new guidance on a national level – competent authority view
• Japanese National Institute for Basic Biology on recent developments in Japan
Challenges for Ecotoxicology
• Update on the new version of the OECD guidance document 150
Challenges for Toxicology
• Overview and evaluation of the effects of EDs on testicular function
• The assessment of thyroid(-related) toxicity
Integrating Information for ED
• Consensus modelling approaches to predict estrogen and androgen receptors activities
• Insight into theoretical and experimental approaches for application of the Adverse Outcome Pathway concept
Special: Risk Communication
• The German Federal Institute for Risk Assessment (BfR) on risk communication with regard to endocrine disruptors
20 and 21 November 2018 in Cologne/Germany
Endocrine Disruptors9th International Fresenius Conference
Updated Programme
8.30 Registration and coffee
9.00 Welcome address by Akademie Fresenius and introduction by the Chair
Lennart Weltje, BASF, Germany
Regulatory Developments in Europe9.10 New criteria for ED identification under EU Regulations on plant protection products and on biocidal products
Representative of the European Commission’s DG SANTE, Belgium (confirmed)
9.35 Questions and answers
9.40 Guidance document for the implementation of the ED criteria for biocides and pesticides
• Introduction of the joint guidance document• Proposed assessment strategy• Concerns raised during public consultation• Implication of the guidance for other legislative
frameworks• Implementation of the ED guidance document for
plant protection products
Niklas Andersson, European Chemicals Agency (ECHA), Finland and Domenica Auteri, European Food Safety Authority (EFSA), Italy
10.20 Questions and answers
10.30 The journey from reports of decreasing semen quality in men to the EU criteria for identification of endocrine disruptors: A member state regulatory authority perspective
• The origin of endocrine disruptor toxicology• The development of criteria for ED identification• The implications for chemical regulation in Europe• The impact of the new EFSA/ECHA guidance
Alan Breen, Department of Agriculture, Food and the Marine, Ireland
10.55 Questions and answers11.00 Coffee break
Tuesday, 20 November 2018
11.30 Implementing the ED guidance document on the national level• Interpretation of the ED guidance• Use of expert judgement• Uncertainty analysis
Emily McVey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands
11.55 Questions and answers
12.00 Implementing the EDC criteria – an NGO perspective
• Critical points in the guidance document for ED identification
• Priorities for research and speeding up regulatory controls
• EU EDC Strategy – the need to close current policy gaps
Ninja Reineke, CHEM Trust, United Kingdom
12.25 Questions and answers
12.30 Implementing the guidance document: Welcome content and regulatory challenges – an industry view
Jean-Pierre Busnardo, Corteva Agriscience, Belgium
12.55 Questions and answers13.00 Lunch
Developments Outside Europe14.30 Endocrine Disruptors: Recent developments in Japan. Strategies and recent results of TG240 (MEOGRT)
Taisen Iguchi, National Institute for Basic Biology, Japan
14.55 Questions and answers
Challenges for Ecotoxicology15.00 OECD guidance document 150 - how has the second edition been changed?
• The original guidance document 150• New OECD test guidelines and updated document• Comparison of original and new guidance• Advantages of the updated version
Peter Matthiessen, Independent Consultant, United Kingdom
15.25 Questions and answers15.30 Coffee break
16.00 Ecotoxicology challenges for the identification of endocrine disruptors
• Ecotoxicological testing for the determination of endocrine disruption hazard
• Testing strategy and guideline issues• What is a conclusive weight-of-evidence?
James Wheeler, Corteva Agriscience, United Kingdom
The ProgrammeGet-Together on Monday, 19 November 2018Will you arrive on Monday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.
Wednesday, 21 November 2018
16.25 Questions and answers
16.30 Population relevance of endocrine disruptors for non-target vertebrates
• Operational approaches to evaluate population relevance
• Specific Protection Goals for focal wildlife populations• The use of individual-based population models to
determine thresholds between negligible and non-negligible (i.e. adverse) population level effects
• Potential contribution of field data
Laurent Lagadic, Bayer, Germany
16.55 Questions and answers and final panel discussion17.45 End of first day19.00 Departure time for the evening event
9.00 Welcome address by the Chair
Emily McVey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands
9.10 The use and misuse of histopathology in endocrine disruptor testing
• Technical aspects and pitfalls to consider• Correlation to biomarkers like vitellogenin• Decreasing quality of histopathology data in
publications
Lisa Baumann, University of Heidelberg, Germany
9.35 Questions and answers
Challenges for Toxicology9.40 Appendix A of the ED Guidance document – how can we assess thyroid(-related) toxicity?
• Direct vs indirect thyroid toxicants• Connection between T4 and adverse
neurodevelopment• Human relevance of thyroid effects seen in rats• Assessment of developmental neurotoxicity
Stephanie Melching-Kollmuss, BASF, Germany
10.05 Questions and answersInformation available online at: www.akademie-fresenius.com/2589
After the end of the first conference day, Akademie Fresenius would like to invite you to a leisurely dinner at the restaurant Joseph‘s in the Rheinau harbour. 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!!
10.10 Endocrine disruptors and male infertility
• Systematic literature review• Evaluation of the effects of EDs on testicular function• Semen quality and Hypothalamus – pituitary –
testicular axis
Stefania Lymperi, Aristotle University of Thessaloniki, Greece
10.35 Questions and answers10.40 Coffee break
Integrating Information for Endocrine Disruptors11.10 Consensus modelling approaches to predict estrogen and androgen receptors activities
• Importance of screening/assessment • Classic approaches: Issues and limitations• EDSP program: ToxCast/Tox21 data and goals• Computational toxicology and QSAR modelling• ER & AR pathway models• CERAPP and CoMPARA Consensus approaches
Kamel Mansouri, ILS, Contractor Supporting NICEATM, National Institute of Environmental Health Sciences (NIEHS), United States of America
11.35 Questions and answers
11.40 Connecting molecular information to adverse effects: Theoretical and experimental approaches for application of the Adverse Outcome Pathway concept
• Molecular junctions between the HPG-, HPT-, and HPA/I-axis
• Demonstration of the transferability of AOPs to other life stages
• Integration of high content methods
Elke Eilebrecht, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Germany
12.05 Questions and answers
Risk Communication12.10 Risk communication with regard to endocrine disruptors
• Risk perception• Social science• Policy advice
Mark Lohmann, Federal Institute for Risk Assessment (BfR), Germany
12.35 Questions and answers and final panel discussion13.25 Lunch and end of the conference
The ExpertsNiklas Andersson holds a PhD in
pharmacology and works as a Toxicologist at the European Chemicals Agency (ECHA) with the main focus on issues related
to endocrine disruptors, grouping of substances and read-across approaches. He was also involved in drafting the ED guidance document. Before joining ECHA in 2010, he had more than 15 years of experience of pharmacological/toxicological research from both academia and industry.
Domenica Auteri is an Ecotoxicologist with more than 20 years of experience in the field of regulatory environmental risk assessment of pestici-des. She works at the
European Food Safety Authority (EFSA) as Team Leader of the Ecotoxicology Team in the Pesticides Unit. She has coor-dinated the drafting of the ECHA/EFSA ED Guidance for EFSA.
Lisa Baumann is a Postdoctoral Research Scientist at the University of Heidel-berg. She is specialized in aquatic toxicology with focus on endocrine effects, hepatotoxicity
and immunotoxicity in fish. Special focuses of her work are histopathological analyses for which she is regularly recruited as specialist for contract work and workshops.
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.
Jean-Pierre Busnardo is an Agronomist. He is the Brussels-based EU Regulatory Affairs Leader for Corteva Agriscience – the Agriculture division of DowDupont. Jean-
Pierre is a member of the Regulatory Policy Team of the European Crop Protection Association (ECPA).
Elke Eilebrecht is Head of Ecotoxicology at the Fraunhofer Institute for Molecular Biology and Applied Ecology IME. She holds a PhD in neuroscience, however switched
topics to ecotoxicology in 2010. Her work includes ecotoxicology testing with fish for environmental risk assessment and the identification and evaluation of new test approaches.
Taisen Iguchi is an emeritus Professor at the National Institute for Basic Biology and Professor at Yokohama City University in Japan. He is a member of various governmental
committees related to ED and food safety issues, e.g. at the Japanese Ministry of the Environment. Also, he is a member of OECD VMG and EDTA groups, and chairing UK-Japan and US-Japan ED cooperation projects.
Laurent Lagadic holds a PhD in funda- mental toxicology and has worked as an Aquatic Ecotoxicologist at the French National Institute for Agricultural Research (INRA) for over
20 years. In 2014, he joined the Environ-mental Safety Division of Bayer Crop-Science in Germany. He is involved in aquatic risk assessment for pesticides and biocides, currently with a focus on endocrine-disrupting properties of these substances in aquatic organisms.
Mark Lohmann holds a PhD in bioche-mistry. Since 2010 he has been working as the Head of Unit Risk Research, Perception, Early Detection and Impact Assessment at
the German Federal Institute for Risk Assessment (BfR). His research interests include the realisation of target group-oriented risk communication, the development of methods to determine the influence of social-psychological factors on public risk perception as well as the implementation of systems for the detection of emerging risks.
Stefania Lymperi received her PhD in stem cell biology from Imperial College London. She worked as a Postdoctoral Fellow at Harvard Medical School and Massachusetts
General Hospital in Boston and is currently directing her private Andrology Laboratory in Thessaloniki. In parallel, she is teaching at the master course of the Biology School of AUTH and is a staff of the Training Center of the European Academy of Andrology in Thessaloniki.
Kamel Mansouri, PhD, is leading the computational chemistry efforts at Integrated Laboratory Systems supporting the NTP Interagency Center for the Evaluation of
Alternative Toxicological Methods (NICEATM) at the U.S. National Institute of Environmental Health Sciences (NIEHS). He is working on several projects involving QSAR modelling, cheminformatics, and computational toxicology.
Peter Matthiessen is an Ecotoxicologist with over 40 years’ of experience in the field of aquatic pollution specialised in the study of endocrine disruption. He is the Co-Chair of the
OECD Validation Management Group for Ecotoxicity Tests (VMG-eco) and member of the UK Hazardous Substances Advisory Committee.
Emily McVey is an experienced Toxico-logist and works as a Risk Assessor at the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb). She is focussing on environmen-tal risk assessment - both ecotoxicology and environmental toxicology - and is particularly interested in risk assessment methodology, science communication and policy.
Stephanie Melching-Kollmuss has been working as European and Global Regulatory Toxicologist for plant protection products at BASF since 2006. Her main research interest is
endocrine disruption and combined toxi-city assessment and she continues to be involved in ECETOC and Cefic LRI projects. She is member of the ECPA ED Expert Group and chairs the Cumulative Risk Assessment subgroup of ECPA. Since July 2018 she has been a member of the newly formed ECETOC special T4 taskforce.
Ninja Reineke holds a PhD in chemistry and works with CHEM Trust as Head of Science, with the main focus on improving EU regulation on endocrine disruptors, e.g. within
REACH and the pesticides law. Previously she worked for WWF on EU chemicals policy in Germany and in Brussels.
Lennart Weltje holds a PhD in ecotoxico-logy 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).
James Wheeler works as an Ecotoxicolo-gist for Corteva Agriscience – the Agriculture division of DowDupont. His work focuses on environmen-tal risk assessment and
ecotoxicology testing with a particular interest in fish endocrine test methods.
Who do you meet?Groups that should take part:
Professionals working in the fields of
• Toxicology and ecotoxicology
• Research and development
• Registration, regulatory affairs
• Chemical risk assessment
• 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
About
Organisation and participant management
Danielle Sörries phone: +49 231 75896-74 [email protected]
Do you have any questions?
Trade ExhibitionOur conference provides you with the opportunity of presenting your company in a trade display. Present your products and services and reach out to your specific target groups. We would be happy to provide you with information on all the various options available – from displaying product information to an exhibition stand – with no further obligation on your part.
Use the attached fax reply sheet to request our information material. Or simply call us. We would be more than pleased to assist you perso-nally.
Semsigül Yalcin phone: +49 231 75896-94 [email protected]
The OrganiserFor over 20 years, Akademie Fresenius has been your partner for practice-orientated training on all the latest topics surrounding the safety and quality of food, consumer goods and chemical products along the whole production chain. Our portfolio not only includes inter-national conferences but also offers national trade meetings, intensive practical seminars and training in small work groups.
Our events are designed to promote an active exchange amongst our participants and offer the perfect platform for bringing the industry, the scientific sector, the authorities and the consulting field together. Excellent service, all-inclusive. Our wide-ranging advanced training opportunities contribute to giving our customers the competitive edge in all quality assurance, risk assess-ment, legal, production and techni-cal questions.
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You can find details on upcoming and new events at www.akademie-fresenius.com
Programme and conceptual design
Claudia Werner phone: +49 231 75896-84 [email protected]
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