Event
Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality
Tuesday, August 29, 2023
8:30 a.m.-6:00 p.m.
In-person at Universities at Shady Grove campus in Rockville, Maryland
cersi@umd.edu
In-person at Universities at Shady Grove campus in Rockville, Maryland
The U.S. Food and Drug Administration (FDA)- in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)- will host a three-day in-person workshop entitled “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives” on Tuesday, August 29 through Thursday, August 31, 2023.
The aim of this three-day workshop is to provide a forum for experts from regulatory agencies, innovator and generic drug industry, consultants, academia, and commercial software providers and others in the field of modeling and simulation, to discuss the opportunities and best practices for incorporating drug product quality attributes within PBBM models to support development programs and regulatory submissions. The workshop also aims to identify bottlenecks/gaps which hinder the development and efficient utilization of PBBM models to support drug product quality.
The workshop will include morning presentations of PBBM case studies by global regulatory agencies. Afternoon breakout sessions will provide the opportunity to deep dive into challenges highlighted by the case study presentations and delineate best practices.
Topics:
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Regulatory strategy and applications of PBBM during clinical development, marketing application, and post approval change
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Discussions around a framework for reporting PBBM models
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Challenges and considerations in the development of biorelevant/biopredictive inputs such as solubility, dissolution, permeability etc. for the PBBM model development
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Scientific considerations for establishing verification and validation strategies for PBBM models for their intended purpose of application
To register, please use this link
To view the agenda, please click this link
To view the speaker bios, please click this link
