Module 9 2021

Environmental Risk Assessment

EU: Mandatory in EU for clinical trials and MA US: not required for substances naturally occurring in the environment Requires ● Identification of the GMO and hazards ● Identification of consequences and occurrence ● Risk estimation and mitigation strategy

Complex document highly technical Complex review process during MA ● Already MA product waived from presenting ERA for Clinical trials

Novartis Pharma AG- Business use only- not for further distribution

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