Workshop / 11/09/2017, 9.00 AM - 5.00 PM
Workshop “Environmental Risk Assessment of Veterinary Medicinal Products – Update, Recent Developments and Implications”
In cooperation with the German Federal Office of Consumer Protection and Food Safety (BVL), the Fraunhofer ITEM Department of Chemical Risk Assessment is offering a one-day workshop on environmental risk assessment of veterinary drugs.
Comprehensive environmental risk assessments (ERAs) are essential parts of the registration dossiers, when veterinary drugs are registered and when existing authorizations are modified in Europe. Over the years, data requirements and corresponding dossiers have become increasingly complex. Over the past years, Fraunhofer ITEM in cooperation with experienced partner institutes has gained extensive experience in the environmental assessment of drugs, both in targeted experimental setups and in regulatory requirements and dossier preparation.
This one-day course is a follow-up to the extended ERA workshop conducted in 2013. It will inform representatives from pharmaceutical industry, consulting firms, and other interested parties on basic requirements in environmental risk assessment in national and international regulatory contexts. Moreover, it will update the participants e.g. on recent developments concerning new and adapted guidance documents issued by authorities and help them meet regulatory challenges.
The workshop will be held in English language.