The purpose of ICH Q9 is to ensure a systematic and proactive approach to managing risks that may affect product quality, patient safety, and data integrity. It recognizes that risk management should be an integral part of the pharmaceutical quality system and be applied throughout the lifecycle of a product, from development to post-marketing activities.
Overall, ICH Q9(R1) plays a crucial role in promoting a proactive and systematic approach to risk management in the pharmaceutical industry. It aligns with regulatory expectations and industry best practices, ensuring the delivery of safe and effective pharmaceutical products to patients worldwide.
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry.
This session will discuss some potential applications and tools used in the industry for Quality Risk Management. Additionally, a few examples of how to apply these applications will be reviewed.