Published in November 2018, a draft revision to the EMA guideline on environmental risk assessment (ERA) for human medicines both elaborates on existing guidelines and contains considerable changes. The new draft maintains the original’s tiered approach, but triggers and strategies are now different. How will these changes impact your studies?
View our webinar to learn what you need to know, including results of our retrospective analysis of more than 90 ERAs to determine the effects of the new assessment scheme.
Daphne F. de Roode, PhD, ERT
Senior Regulatory Ecotoxicologist and Environmental Fate Specialist, Regulatory Affairs Department