Predictive Dissolution Models for Real-time Release Testing: Development and Implementation Workshop
IQ Consortium invites you to register for the Predictive Dissolution Models for Real-time Release Testing: Development and Implementation Virtual Workshop taking place 11-12 November 2021.
This workshop will focus on development and implementation of predictive dissolution models (PDM) for real-time release testing (RTRT). The workshop will be organized around a series of talks from industry, academic, and regulatory speakers, each one educating the attendees in different aspects and/or perspectives of the process. An overall introduction of dissolution RTRT will provide the business case for its implementation and the impact it can have on drug product manufacturing and quality, as well as an outline for its general development. A regulatory talk will lay out regulatory experiences with dissolution RTRT and their expectations from the point of view of demonstrating and assuring product quality to patients. A series of industry and academic talks will delve into the technical details of RTRT dissolution model selection and development, such as prediction of dissolution profiles from spectroscopic and/or process data. Next, a series of industry sessions will inform the audience of the currently understood best practices around developing an RTRT model from a dissolution method to address biopharmaceutics risk assessment of predicting performance, on sampling strategy, model requirements, validation, maintenance, and lifecycle. Industrial case studies will be presented to showcase successfully implemented RTRT of dissolution for drug product manufacturing. Ample time will be provided for panel discussions, breakout rooms, and audience engagement and feedback.
Who should attend?
- Pharmaceutical researchers
- in industry, government, or academia with interest in learning and advancing the field of predictive dissolution model development
- engaged in process analytical development looking to adopt or share understanding of developing dissolution models that could complete the RTRT package for low solubility drug products as well as model validation and model lifecycle
- interested in bridging the gap between traditional dissolution specification setting or clinically relevant specifications with predictive dissolution modeling
- Regulators from health authorities interested in predictive dissolution modeling, especially establishing expectations, guidelines, and requirements for dissolution modeling for drug product release
- Individuals willing to share and engage in thoughtful discussion around topics in predictive dissolution model development for RTRT