163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle

In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning established conditions and drug-device combination products. Subhi explains how Q12 enhances lifecycle management, streamlines post-approval changes, and improves regulatory alignment. He breaks down critical concepts such as established conditions, product lifecycle management (PLCM), and post-approval change management protocols (PACMPs). Subhi outlines the benefits and challenges of adopting ICH Q12 and encourages listeners to familiarize themselves with its guidelines.00:00 Introduction and Welcome00:31 Topic Overview: ICH Q12 and Established Conditions01:01 Understanding ICH Q12: Life Cycle Management02:26 Importance of Post Approval Changes04:11 Key Concepts of ICH Q1206:14 Practical Example of ICH Q12 Application07:45 Benefits and Challenges of ICH Q1210:32 Final Thoughts and Encouragement11:26 Closing Remarks and Contact Information