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

Let's Combinate - Combining Drugs and Devices

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 Welcome 00:31 Topic Overview: ICH Q12 and Established Conditions 01:01 Understanding ICH Q12: Life Cycle Management 02:26 Importance of Post Approval Changes 04:11 Key Concepts of ICH Q12 06:14 Practical Example of ICH Q12 Application 07:45 Benefits and Challenges of ICH Q12 10:32 Final Thoughts and Encouragement 11:26 Closing Remarks and Contact Information