Environmental Risk Assessment of Veterinary Pharmaceuticals

3:25 PM - 4:10 PM

An evaluation of the environmental safety for a veterinary pharmaceutical is a pivotal part of a successful regulatory dossier.  For veterinary pharmaceuticals, global regulatory guidance documents available through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) outline the process to generate environmental risk assessments (ERAs).  VICH GL 6 and GL 38 outline the Phase I and II veterinary ERA process, geographic regions, such as Europe, Australia and the United States.  The Phase I process determines the potential exposure in the environment and whether a Phase II assessment is needed.  The Phase II assessment outlines a tiered process with environmental studies aimed at understanding the fate in different matrixes (e.g. soil, sediment, water) and toxicity (e.g. aquatic, terrestrial) of the veterinary pharmaceutical. 
This presentation will discuss the relevant environmental guidance documents, the Phase I and II ERA process, the key environmental fate and ecotoxicity studies, PBT assessments and conclude with several environmental case studies.