ICH Q9: Quality Risk Management Revision Focuses on Six Topic Areas
The recent ICH Q9: Quality Risk Management revision includes new guidance on facilitating a risk-based decision-making approach using science and knowledge. Kevin O’Donnell, PhD, Market Compliance Manager, Irish Health Products Regulatory Authority (HPRA) provided an update on the ICH Q9 revision at the 2021 PDA/FDA Joint Regulatory Conference last fall, ahead of the December 2021 […]