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In November 2019, the International Council for Harmonization (ICH) Q12 guideline entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was finalized. Specifically, ICH Q12 provides a framework to facilitate management of post-approval Chemistry, Manufacturing and Controls (CMC)changes (manufacturing, packaging, microbiological and analytical test methods) in a more predictable and efficient manner. In addition, the guideline addresses the gaps for the implementation and application of ICH Q8, Q9, Q10 and Q11 for the global harmonization of post-approval changes. Furthermore, the ICH Q12 harmonized approach for technical and regulatory considerations for lifecycle management promotes innovation and continual improvement.
This webinar will provide an overview of the guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed.
This webinar will appeal to all technical, quality operations and regulatory personnel in drug or combination product development and commercialization.
DLK Consulting Services, Inc.
Chief Scientific Officer