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

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Manage episode 451097499 series 3325357
Content provided by Subhi Saadeh. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Subhi Saadeh or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.

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

  continue reading

188 episodes

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iconShare
 
Manage episode 451097499 series 3325357
Content provided by Subhi Saadeh. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Subhi Saadeh or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.

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

  continue reading

188 episodes

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