ICH Q9 Risk Management Revision and Practical Applications for ATMPs

ICH Q9(R1) – Quality Risk Management (QRM) is currently being revised, and step 2 is expected to be reached by end of 2021. The update of this guideline is anticipated to benefit ATMP by fostering increased use of science based QRM activities.
Advanced therapy medicinal products (ATMPs) are medicines that include a wide range of different products. Due to their complexity, the approaches used in the development, manufacture and control of well characterised biological products may not be fully applicable. A pro-active risk-based approach is essential to drive the product development and determine the extent of quality, non-clinical and clinical data required.
This session will provide an update on ICH Q9 development and discuss the importance of Risk based approaches and QRM in the development of ATMP.