EFSA is organising a workshop for stakeholders involved in the peer review of pesticides and with experts in the field of in vitro metabolism studies.
The EU pesticides Regulation 283/2013 on data requirement established that “Comparative in vitro metabolism studies shall be performed on animal species to be used in pivotal studies and on human material (microsomes or intact cell systems) in order to determine the relevance of the toxicological animal data and to guide in the interpretation of findings and in further definition of the testing strategy”.
These studies are the basis for the identification of human metabolites. In addition, metabolism studies have a relevant role in understanding endocrine mediated mechanisms of toxicity and human relevance of animal data in a weight of evidence approach (e.g. endocrine mediated-thyroid toxicity).
Experts will :
- Define the minimum amount of information that should be provided to satisfy the data requirement.
- Define the information that should be included in the study protocols.
- Discuss the key elements to be considered for the interpretation of the study(ies) outcome
- Discuss how metabolism data can be used in a weight of evidence approach for endocrine mediated mechanisms of toxicity
This is the preliminary conference programme subject to changes.
Tamara Coja (AGES, Vienna, Austria).
|1st general session:||
Chair: Tamara Coja (AGES, Vienna, Austria ).
01. Introduction to the “In vitro comparative metabolism project” in the pesticide regulatory context.
|Juan Manuel Parra Morte (EFSA Pesticides Unit).|
|14.30||02. A framework to characterize in vitro hepatic metabolism across species for regulatory applications.||
Sandra Coecke (European Commission, JRC, EURL-ECVAM, Ispra, Italy).
03. In vitro comparative metabolism studies to identify metabolites using microsomes: standards and criteria for acceptability and interpretation.
Khaled Abass (University of Oulu, Institute of Arctic Medicine, Finland).
|15.30||04. In vitro comparative metabolism studies to identify metabolites using hepatocytes: standards and criteria for acceptability and interpretation.||
Ugo Zanelli (Discovery DMPK, Merck KGaA Darmstadt. Frankfurt Am Main Area, Germany).
|16.30||05. Identification of metabolites: analytical challenges for conducting in vitro metabolism characterization of pesticides.||
Maria Anna Fedrigo (Aptuit and Evotec Company, Verona, Italy).
|17.00||06. Industry view: In vitro comparative metabolism studies to identify metabolites.||Paul M. Whalley (Syngenta, Bracknell, UK on behalf of ECPA).|
|17.30||07. In vitro studies to assess liver enzyme induction across species. Standards and criteria for acceptability and interpretation.||
Simona Marzorati (Accelera SRL, Milano, Italy).
|18.00||08. Investigating thyroid disruption through liver enzyme induction using hepatocytes.||
Vicki Richardson (US EPA, Durham, North Carolina. USA)
Michael DeVito (NIH/NIEHS, Durham, North Carolina. USA).
|Closing remarks||Andrea Terron (EFSA Pesticides Unit).|
|18.30||End of general session 1|
Break-out session 1:
Chair: Emanuela Testai (Istituto Superiore di Sanita, Rome, Italy).
Rapporteur: Marina Marinovich (Milan University, Milan, Italy).
Break-out session 2:
Chair: Sharon Munn (JRC, EURL-ECVAM, Ispra, Italy).
Rapporteur: Alfonso Lostia (EFSA, Pesticide Unit).
|2nd general session:||Chair: Tamara Coja (AGES,|
|14.00||Feedback from Break out session 1|
|15.00||Feedback from Break out session 2|
|16.30||End of the Workshop|
Who should attend
Stakeholders dealing with the peer review of pesticides and experts in the field of in vitro metabolism studies. The outcome of the workshop will be usedto developan EFSA guidance document. Participants will be selected to ensure a sufficient representation of the different stakeholders, fields of expertise, and geographical balance. Register here by 22 October.
Date and venue
The conference will be held on 15 and 16 November 2018 in Parma, Italy. The venue will be communicated to selected participants after the close of registrations.
English will be the official language of the conference. No translation will be provided.
Feel free to contact us about any content-related matters or organisational and logistical issues at the following address: events [at] efsa.europa.eu.