ICH Q12 Unpacked: Established Conditions & Post-Approval Changes

Understanding ICH Q12 and Its Impact on Pharma Lifecycle Management

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


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