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Prospects for Post-Approval Change Management

by Naheed Sayeed-Desta, Apotex, Ajay Babu Pazhayattil, and Ivy Louis, Vienni Training and Consulting LLP

Published On May 29, 2018

As new types of biologic products enter the market, the need for innovative processes continues to grow. This requires improvements in post-approval change management. ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management offers a solution to post-approval change challenges in the form of a post-approval change management protocol (PACMP) (1).

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