Optimizing Your ERA Study Designs

Applications for drug approvals in US and European markets must include a complete environmental risk assessment (ERA) to evaluate the potential impact of the drug substance on the environment. The regulation applies to both new and existing products with certain use variations and can be a lengthy and involved process – potentially taking a number of years to complete.

Both the US and European regulatory authorities require pharmaceutical companies to assess the potential impact of their drug substance on the environment. In this second of a two-part webinar series, we focus on optimizing the design of your environmental toxicology studies to generate the data you need.

Presenters

  • Chris Lowrie, BSc, Head, Head, Environmental Fate and Metabolism, Charles River
  • Marcel Migchielsen, BSc, Head, Environmental Science, Charles River


Please see the links below for the replay of the other webinar in the series:

Regulatory Considerations for Environmental Risk Assessment