Study Evaluation/Interpretation
CEA has extensive experience in the evaluation of environmental fate and ecotoxicology data sets in the context of current regulatory criteria. Through the interrogation of existing data it may be possible to improve the interpretation of environmental fate and /or effects of chemicals. In certain cases this may avoid the need for expensive higher-tier studies. Alternatively data evaluation can identify shortcomings in existing data sets and help to identify specific additional studies needed for regulatory compliance.
The effective communication to regulatory authorities of such complex and sophisticated information concerning risk assessments is a strength of CEA. We can assist in the development of clear risk assessment strategies, lead discussions with regulatory authorities and prepare customised, high quality reports for regulatory submission.
CEA also has wide experience in the compilation of expert reports for clients. Examples include combining information from environmental reports with selected published data from literature searches to formulate a more comprehensive risk assessment; preparation of summaries and overviews of environmental fate and ecotoxicology, and comparisons between environmental risks of different products with related use patterns.
The combination of our regulatory and technical expertise ensures the best evaluation of available data in the context of current regulatory requirements.
Recent Studies :
- Review of existing data and peer reviewed papers to produce expert reports for fish medicines under Directive 2001/82/EC.
- Review of a regulatory mesocosm study and expert opinion on the setting of an Ecologically Acceptable Concentration (EAC) under Directive 91/414/EEC.
- Evaluation of higher-tier ecotoxicology data for Member State registration under Directive 91/414/EEC.
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