CMC Workshop: From Drug Development to Global Supply to Patients

This session will feature speakers willing to expand upon some of the more challenging issues for the API supply chain as they relate to ICH Q11 (Development and Manufacture of Drug Substances). ICH Q11 provides opportunities for improving regulatory global harmonization expectations for dug substance development and manufacture. However, implementation of ICH Q11 may not necessarily align with region to region interpretations and/or current regulations. For example, the interpretation and assessment of criticality of quality attributes and process parameters, the justification of a design space based on small-scale models, the development of a holistic control strategy, and the role of post-approval process verification have varied interpretations form both industry and regulatory authorities.