PBBM Best Practices for Drug Product Quality: Regulatory and Industry Perspectives Workshop
  • - Past
  • All Day
  • Grand Mercure SP Itaim Bibi, Sao Paulo, Brazil

Join ICF and the Simulations Plus Team, Scientist I Daniela Silva, Fellow of Regulatory Affairs Gustavo Mendes, and Principal Scientist & Scientific Lead (South America) Frederico Martins for this collaborative event to advance the use of PBBM and identify best practices through case study evaluations.

PBBM is an evolving approach that can be used throughout drug product development, regulatory approval, and life cycle management. PBBM focuses on providing a mechanistic understanding of how drug product quality attributes interact with physiology, influencing the in vivo drug performance. This workshop will discuss scientific practices for developing PBBM models for orally (and dermally) administered drug products and how these models can be leveraged for streamlining pharmaceutical development and supporting manufacturing changes and controls.

This workshop will be conducted in Portuguese.