Q12 Aims to Align CMC with Accelerated Development & Approval
DIA: Driving Insights to Action

Q12 Aims to Align CMC with Accelerated Development & Approval

2017-03-28
Dr. Moheb M. Nasr, who serves as Vice President, CMC Regulatory Strategy for GlaxoSmithKline, is a member and rapporteur of the Expert Working Group for the ICH Q12 Guideline, Technical and Regulatory Considerations for the Pharmaceutical Product Lifecycle. “We realized that the ICH 8 through ICH 11 Guidelines were mostly on the development stage of the life cycle, and there is a gap that needs to address the commercial phase of the life cycle,” he explains in this exclusive Global Forum pod...
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