
Regulatory Summit on ICH Q9 Revision
Global regulators including members of the ICH Q9(R1) Expert Working Group will participate in discussions on the background, issues, and status of the ICH Q9 revision and provide perspectives on the current state of application of quality risk management in industry. Discussion panels and breakouts will address practical implementation of the key focus areas of the ICH Q9 Revision: Subjectivity, Product Availability, Formality, Decision-making, Digitization and New Technology/Modalities. Attendees will be able to provide their thoughts to regulators on the training needed to implement the updated ICH Q9.
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