Workshop announcement: Physiologically based biopharmaceutics modeling (PBBM) - Sep. 23-25, 2019

Workshop Announcement Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls September 23-25, 2019 Register Now (limited to 160 participants) Physiologically based biopharmaceutics modeling (PBBM) can facilitate the incorporation of clinical relevance in product quality from initial development through marketing approval to lifecycle management, thereby minimizing the need of additional in vivo bioequivalence studies, leading to reducing cost in product development and supporting regulatory decisions. The purpose of this workshop is to identify and begin to fill the gaps in knowledge on the use of PBBM for drug product quality (e.g., to study in vivo impact of formulation and manufacturing changes). View Agenda Interact and discuss PBBM strategies with experts from: Academia Regulators, to include: U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, and Pharmaceuticals and Medical Devices Agency (PMDA) Industry researchers

This workshop is a collaboration by FDA | CDER Office of Pharmaceutical Quality (OPQ), Small Business and Industry Assistance (SBIA), and University of Maryland CERSI