Methodology for environmental risk assessments in medical and veterinary biotechnology

Over time, the COGEM has composed and reviewed a large number of ERAs relating to human and veterinary medicine research and development. While each case has been evaluated on the basis of its specific characteristics, a general methodology evolved. This review presents a synopsis of the COGEM methodology based on a thorough analysis of its advices, as well as legal and scientific instruments underlying the formulation of an advice to the competent authority.