CMC Workshop 2015

The concepts described in ICH Q8, Q9, Q10 and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. However full implementation of these concepts have not been realized mainly with regards to assessing changes across the life cycle of pharmaceutical products. Several gaps exist which limit intended benefits: criteria for a harmonized risk-based change management system that effectively evaluates the impact of change on quality, clarity of the expectations of a knowledge management system that ensures continuity of product and process information, and appropriate level of detail and information sufficient for regulatory assessment and inspection.

Leading regulators, from Europe and the United States, will join industry speakers to share their perspectives on this topic and provide an update on progress made to date. Presentations will be followed by panel discussions.