Managing Pharmaceutical Product Lifecycle: ICH Q12 Insights

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The presentation on "ICH Guideline Q12" offers an informative overview on managing post-approval changes in pharmaceuticals, facilitating innovation while maintaining quality. It covers objectives such as efficient change management for chemistry, manufacturing, and controls (CMC), and outlines regulatory tools like Established Conditions and Post-Approval Change Management Protocols. The role of a Product Lifecycle Management Document is emphasised as a central hub for tracking changes....