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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.

  • Global Supply Chain and Drug Shortages: Strategies to ensure continuity of manufacturing and prevent shortages amid global supply chain challenges
  • Structured Product Quality Data and Submissions: Leveraging structured data to enable harmonized global CMC dossiers and improve regulatory submissions
  • Innovative Technologies in CMC and Quality: Exploring advanced technologies, digital tools, and innovation to enhance manufacturing and product quality
  • Regulatory Trends and Substances of Concern: Understanding evolving regulations and approaches for managing materials and substances of concern
  • Global Inspections and Lessons Learned: Insights from regulatory inspections, evolving expectations, and practical takeaways for compliance
  • International Convergence and Harmonization: Updates on collaborative global efforts to harmonize CMC and product quality standards
  • CMC Acceleration Strategies: Legislative pathways, regulatory flexibility, and pilots that enable faster development while maintaining quality and safety
  1. How can global supply chain vulnerabilities be addressed to ensure consistent drug availability and prevent shortages?
  2. What advancements in data structuring and digital submissions are shaping the future of a single global CMC dossier?
  3. How are regulatory agencies evolving expectations around inspections, substances of concern, and harmonization efforts?
  4. What innovative approaches, technologies, and regulatory flexibilities are driving accelerated CMC development while maintaining quality standards?

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