CMC Workshop

While the concepts in ICH Q8, Q9, Q10, and Q11 provided opportunities for a more science- and risk-based approach for assessing changes across the life cycle, several gaps exist which limit full realization of expected regulatory flexibility. These gaps include harmonized change management best practices that effectively evaluates the impact of change on quality, clarity of the regulatory commitments (established conditions) in regulatory files and distinguishing them from supporting information, and the development and submission of product specific life cycle management strategy document in regulatory files. ICH Q12 industry and regulatory experts will share their perspectives on ICH Q12 and provide an update on progress made to date. Presentations will be followed by panel discussions.