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ICH Q12 to Foster Post-Approval Change Management

 
• By Bowman Cox

Expert working group forming to develop Q12 guideline to explore “regulatory commitments” concept and proactive post-approval change management plans. But there will be challenges and the devil, as always, will be in the details.

A Q12 guideline the International Conference on Harmonization’s steering committee Sept. 9 agreed to develop would enable pharmaceutical companies to more easily harmonize and improve their global manufacturing processes.

ICH is forming an expert working group to convene at its Nov. 8-13 meeting in Lisbon, Portugal, and begin shaping...

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