IMI2-2019-17-03 - Intelligent prediction and identification of environmental risks posed by human medicinal products

Specific Challenge:Pharmaceuticals are present in the environment as a consequence of patient use, manufacture, and improper disposal. They predominantly enter the aquatic environment via patient use. In the European Union (EU) an environmental risk assessment (ERA) is required as part of the marketing application and approval for new drugs. Currently the ERA is conducted late in drug development and often parallel to Phase III clinical trials and after significant investment.The growing regulatory and scientific concerns regarding pharmaceuticals in the environment have reached the point where [...]