Hardware Podcasts

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

Let's Combinate · 20 Nov 2024 · 11m

What this episode covers

Host Subhi Saadeh explains ICH Q12, a regulatory guideline for pharmaceutical lifecycle management that specifically addresses drug-device combination products. He details how the framework uses 'established conditions' (ECs) to streamline post-approval changes, reducing regulatory friction and improving patient access. The episode breaks down key concepts including Product Lifecycle Management (PLCM) documents and Post-Approval Change Management Protocols (PACMPs) to help sponsors navigate complex regulatory submissions more efficiently.

Most relevant to

large enterprises

Topics

Mentioned

Also
ICH Q12, ICH Q8, ICH Q9, ICH Q10, ISO 14971

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