Quality Risk Management – ICH Q9 (R1) This topic has 2 replies, 3 voices, and was last updated 11 months, 2 weeks ago by . Viewing 3 posts - 1 through 3 (of 3 total) Author Posts August 27, 2023 at 2:51 am #4374 Pharma DigestsPharma Expert What are the major changes in recently updated ICH Q9 (R1) guideline? November 28, 2023 at 4:46 am #4765 aidParticipant The revised Guideline addresses what constitutes formality in QRM and it outlines how varying degrees of formality may be applied during QRM activities, including when making risk-based decisions. December 19, 2023 at 1:55 pm #5466 BelalParticipant To clarify the QRM formalities and risk-based decision making. Author Posts Viewing 3 posts - 1 through 3 (of 3 total) You must be logged in to reply to this topic. Log In Username: Password: Keep me signed in Log In