The objective of this workshop was therefore to gather structured, experience-based input from industry on the control, governance, and mitigation measures applied throughout the AI system lifecycle, with particular emphasis on the application of ICH Q9 quality risk management principles.
To facilitate this discussion, industry stakeholder associations registered with European Medicines Agency (EMA) collaborated to provide a consolidated response to the List of Questions previously shared with industry and delivered during the workshop a series of presentations reflecting a collective industry perspective across the six predefined topics.