EU/EMEA Environmental Risk Assessment: 10 Strategies for Compliance
Click here to listen to an interview with Jennifer Saxe.
Now that the European Medicines Evaluation Agency (EMEA) has expanded its environmental risk assessment (ERA) guidelines, are you certain you know what is required to market your drug in the European Union (EU)?
Marketing a new drug in Europe now means a battery of lab tests and data analyses to determine the environmental impact of its storage, use and disposal. The combination of studies and assessments varies depending upon the characteristics of the drug compound. Compliance with these guidelines can be difficult and costly.
But you can design a program to market your drug in the EU that will meet these prerequisites yet keep costs under control.
Jennifer Saxe will examine the EMEA's ERA with an eye toward cost-effective compliance. She'll describe opportunities for reusing data generated during drug development for use in the ERA, and opportunities for reusing data generated during ERA testing. She'll consider possibilities for exclusions, such as with low-dose pharmaceuticals and alternative testing methods. She'll provide a timeline for lab testing and generating the ERA, and explain what to do if environmental risks of a drug cannot be ruled out.
Order now for your entire team to listen and discover:
- 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
Order now and discover the best strategies to meet these new guidelines when you market your drug in the EU.