Understanding the guidance for identifying endocrine disrupting chemicals


    Workshop leaders:

    Michael Werner Michael Werner
    Managing Director, Prosacon GmbH, Germany
    Martina Duft Martina Duft
    Senior Expert Regulatory Ecotoxicology, knoell Germany GmbH
  3. Introduction on endocrine disruptors: regulatory background, history, criteria and guidance

  4. Stepwise approach: overview on the main requirements of the new guidance

  5. First steps: Gathering and assembly of data – targeted literature search, data bases, QSAR profiling and reporting of data

  6. Investigation of ED properties with a focus on EATS endpoints: Specific toxicological and ecotoxicological study types

  7. Coffee break

  8. Identification and assessment of ED properties for human health and environment: evaluation of all available data

  9. Assembly of the lines of evidence, evaluation of completeness of data

  10. Weight of evidence evaluation: bringing together an overall argumentation

  11. Mode of Action Analysis – assessing the biological plausible link between observed effects and ED activity

  12. Lunch

  13. Regulatory consequences for applicants and overall implications on dossier preparation: Derogations human health/environment

  14. Discussion

  15. End of workshop