From Disconnect to Harmony: Integrating ICH Q9, E6, and E8 for Robust Risk Management in Drug Development

Session details:

This presentation will explore the challenges posed by the disconnect between traditional product-focused risk management frameworks and the specific needs of clinical trials, as outlined in ICH E6 and E8 principles. A compelling case study will be presented highlighting the development of an Integrated Risk Management Storyboard that harmonizes the principles of ICH Q9 with ICH E6 and E8. Attendees will gain valuable insights into how this unified framework enhances regulatory compliance, fosters clear communication among stakeholders, and promotes a proactive risk management culture, showcasing the importance of aligning risk management practices across the product lifecycle.  
 
Don't miss this opportunity to learn about innovative strategies that can transform risk management in clinical trials and ensure operational efficiency.