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Track 10: Regulatory CMC and Product Quality

The Regulatory CMC and Product Quality Track provides a comprehensive view of risk-based approaches across the product lifecycle. The track scope spans from the scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions address the increasing regulatory complexity of development and manufacturing for worldwide markets, accelerated development timelines, new technologies, emerging regulations, and increased scrutiny of manufacturing operations and data.

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