Working group 4

Objectives: Coordination of the R&D programs innovative strategies and compliance with the overall environmental impact to provide a sharable guideline-like document. This may inform the compounds probability of exposure, an information derived from a more detailed understanding on the substances environmental fate. The validation against the ecological interpretation of selected indicators (see below) is important to properly inform drug designer and managers of environmental risks compared to societal benefits.

T4.1 Identify the most relevant ecotox aspects emerged from WG1-WG3 activities, identify the life cycle principles included in the whole discovery & development design for the responsible pharmaceutical use and disposal, improved environmental monitoring and risk assessment of the drugs (D4.1).

T4.2 Critical assessment of the steps necessary to achieve the dual sustainable goals of improving health and protecting the environment. T.4.2 addresses the challenges offered by ecotoxicology and identifies the various possibilities to assess the environmental effects of pharmaceuticals and their degradation products or metabolites following a tiered approach and foster their prevention (D4.2).

T4.3 Concerted activity of receptor-based and biomarker assays to screen pharmaceuticals (preclinical and clinical) effects using small volumes of the drug or its degradation product. (D4.3)

T4.4 Strengthening of omics technologies as impressive possibility to identify potential molecular initiating events in organisms central to ecosystems and their functioning. Selection of test species for these ecotoxicology experiments (D4.4). The achievements from the above studies are important for the development, validation and use of adverse outcome pathways at early stages of the design of antiparasitic drugs. The validation against the ecological interpretation of such indicators is important to properly inform drug designer and risk managers which balance amongst those environmental risks with societal benefits.