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The digital revolution in medicine manufacturing offers opportunities for better understanding and control of the manufacturing processes and therefore better quality of medicines for patients and faster scale up/out with positive impact on medicine availability. The presentation will provide an overview of EU Regulators’ initiatives to support the rapid growth of advance manufacturing technologies. It will present the role of the Quality Innovation Group (QIG), activities at international level aiming towards convergence as well as some key learnings from the QIG Listen and Learn Focus Group meeting on digital tools in manufacturing and control.