Environmental Risk Assessment of Veterinary Medicinal Products

In cooperation with the German Federal Environment Agency (UBA) and the Fraunhofer Institute for Molecular Biology and Applied Ecology IME, the Department of Chemical Risk Assessment of the Fraunhofer ITEM will be offering a 3-day workshop on environmental risk assessment of veterinary drugs. Since 1998, the competent authorities have been asking for comprehensive assessments of the environmental risks when veterinary drugs are registered and also when existing authorizations are modified in Europe. Over the years, data requirements and corresponding dossiers have become increasingly complex. By collaborating with the Fraunhofer IME, which conducts experimental studies on the environmental behavior and on ecotoxicological endpoints, the Fraunhofer ITEM has gained extensive experience in the environmental assessment of drugs over the past years. Representatives from pharmaceutical industry, consulting firms, and other interested parties will have the opportunity to acquire both basic and specific knowledge in environmental risk assessment in national and international regulatory contexts. The workshop will be held by scientists of the ITEM, IME, and UBA in English language. 

Since attendance is limited to 60 participants, we would encourage early registration using the on-line registration form. Registration will be possible until September 20, 2013.

Preliminary program:

Tuesday, October 22, 2013

13:00    Check-in, registration, welcome coffee

14:00    Official welcome, introduction and logistics

14:15    Individual talks:

• Veterinary medicinal products in Europe          
• Regulatory background
• Ecological background
• Phase I assessment
• Phase II assessment

18:30    End of talks

20:00    Dinner

Wednesday, October 23, 2013

08:30    Individual talks:

• Physico-chemical studies           
  
• Fate studies
• Exposure calculations
• Aquatic studies
• Terrestrial studies
•  Risk characterization

12:30    Lunch

14:00    Risk mitigation

PBT assessment

ERAs in consortia

15:00    Exemplary case studies I (break-out groups)

18:00    End of talks and sessions

20:00    Dinner  

Thursday, October 24, 2013

08:30    Individual talks

09:00    Exemplary case studies II (break-out groups)

12:00    Closing session/individual questions

13:00    Lunch

14:00    Expected end of the course