Track 7: Regulatory CMC and Product Quality
This track provides a comprehensive view of risk-based approaches across the product lifecycle, from early product and process development to lifecycle expectations for global regulatory CMC submissions, CGMP compliance, and quality systems. Sessions will explore the increasing regulatory complexity of development and manufacturing for worldwide markets, accelerated timelines, new technologies, emerging regulations, and evolving expectations for manufacturing operations and data integrity.
Themes:
Key Questions to be Addressed:
Expand Your Expertise:
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Drug Development Phase 3 and Regulatory Review
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Advanced Pharmacovigilance Audits and Inspections
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Discovery and Pre-Clinical Phases
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Drug Development and Lifecycle Management eLearning Program
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Informed Consent: Comprehensive Concepts and Components
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Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies
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