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.
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Jennifer Saxe, Ph. D., is an environmental risk assessor and the founder of EcoSafety Sciences, an ecological risk and safety evaluation consulting firm. She has worked for more than five years with global pharmaceutical development clients to effectively address the evolving EMEA ERA guidelines. Jennifer has spent more than a decade designing effective solutions to a wide range of questions about the behavior of chemicals in the environment and chemical exposure and safety in ecological systems.
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