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Experience and Perspectives on OECD 443, the Extended One-Generation Reproductive Toxicity Study
Since its adoption in 2011, the extended one-generation reproductive toxicity study (EOGRTS; OECD 443 test guideline) has become a key milestone in the assessment of potential effects of chemicals on fertility and development, including effects upon the developing nervous and immune systems. ECHA will normally require an OECD 443 for any chemical in the >100 tonne band, or at a lower tonnage if it has endocrine disruption potential.

This complex study also offers an opportunity to improve animal welfare, through reduction and refinement, in a modular (cohort) study design. The challenge for a CRO is to manage all cohorts, especially when those are triggered based on findings noted during the EOGRTS itself.
Thanks to comprehensive expertise in Developmental and Reproductive Toxicology, Citoxlab has the experience and know-how required to manage such a complex study.

In this Webinar, using experience gained during the execution and reporting of EOGRTS, Citoxlab will present the lessons learned in conducting full tests, discuss the development and benefits of performing such a study, and focus on the challenges faced both by registrants and CROs in meeting the volume of demand for EOGRTS in the coming years.

Dec 17, 2018 2:00 PM in London

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Speakers

Glyn Horner
Business Development Director. @Citoxlab
Over his career, Glyn has spent a decade working in the CRO industry starting as a study coordinator working on ADME/toxicology/residues and environmental testing programs. With 20 years’ experience in commercial roles within the scientific research sector and 8 years in CRO Business Development, Glyn currently focusses on the agrochemical and industrial chemical markets for Citoxlab in Europe in his role of Business Development Director.
David Esdaile
Director of Science and Regulatory Affairs @Citoxlab
David Esdaile has over 35 years experience in most areas of Toxicology, from QSAR to In Vitro, Reprotox and Chronic Toxicology. He was head of toxicology at Shell Research in Sittingbourne in the UK, then head of predictive and explanatory toxicology at the Sophia Antipolis research centre (Rhone Poulenc, Aventis, then Bayer Cropscience) and now is the Director of Science and Regulatory Affairs at Citoxlab in Hungary.
Judit Hargitai
Associate Scientific Director @Citoxlab
Judit Hargitai has been working for more than 20 years in toxicology. She has over 10 years study director experience including wide range of studies from genetic toxicity to reproductive toxicity, currently focusing on the scientific management of long-term studies in her role of Associate Scientific Director at Citoxlab in Hungary.