Events for Food and Drug Administration (FDA)

EU/EMEA Environmental Risk Assessment:10 Strategies for Compliance

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Factors that determine when a full Phase II ERA is necessary and when it can be omitted from the application dossier
What to expect for a basic Phase II ERA, including tests, reports, costs and time to completion
Ten tips and strategies to make your risk assessment the most cost-effective
Four characteristics that can be used for early identification of compounds that will require a more complicated, costly and time-consuming assessment
What to expect when the ERA outcome suggests that the use of a compound could lead to adverse ecological effects
How and why the data generated for an ERA should be leveraged for other purposes

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