Regulatory Considerations for Environmental Risk Assessment

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 first of a two-part webinar series, we outline the regulatory requirements that will impact your ERA program design.

Presenter

  • Dr. Daphne F. de Roode, PhD, ERT, Regulatory Affairs Manager, Regulatory Affairs Department, Charles River


Please see the links below for the other webinars in the series:

Optimizing Your ERA Study Designs