Genotoxic and Elemental Impurities Webinar

Our Toxicology Expert and CEO, Carla Landolfi, has been invited to give a talk on ICM M7 guideline: beyond synthesis and process-related impurities in pharmaceuticals; application and perspective to the webinar on Genotoxic and Elemental Impurities organized by Volanthen Group.

Usually, when we talk about M7 we are talking about a process related substance or a degradation product. In this presentation, she talked about the use of M7 principles and methodologies in safety evaluation and in defining the safety limits of contaminants released in drugs and medical devices through contact materials. She mentioned principles that can be used to define the PDE for data- poor substances of residuals during cleaning procedures in shared facilities and she shown methods to ensure a safe environment in the workplace when data-poor substances are managed.