Joint Biologics Working Party/ Quality Working Party/ Good Manufacturing and Distributing Practice Inspectors Working Group – European industry workshop on lifecycle management

Date: 28/10/2015 to 29/10/2015
Location: European Medicines Agency, London, UK

Product lifecycle management is the focus of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q12 guideline which is currently under development. This guideline aims to provide a framework to facilitate the management of post-approval chemistry, manufacturing and controls changes to the pharmaceutical and biotechnology sectors in a more predictable and efficient manner. It is hoped that this will promote innovation, continual improvement and assurance of supply of medicines. This workshop will gather input from European stakeholders with invited observers, including members of the expert working group, on the core expectations for the ICH Q12 guideline, the design of the proposed ICH Q12 tools and enablers, and their application to typical post-approval changes. The output from the workshop will be used to inform the further development of the ICH Q12 technical document.



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