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DIA 2027 · San Diego, CA

Track 7: Regulatory CMC and Product Quality

This track explores science- and 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 explore the increasing regulatory complexity of development and manufacturing for global markets, accelerated development timelines, emerging technologies, evolving regulations, changing expectations for manufacturing operations and data integrity, and opportunities to enhance global regulatory harmonization and convergence.

Themes
  • 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; use of Quality standards
  • Innovative Technologies in CMC and Quality: Exploring advanced technologies, digital tools, artificial intelligence, 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 Regulatory Collaboration and Harmonization: Updates on collaborative global efforts to harmonize CMC submissions and product quality standards, and regulatory reliance and collaboration initiatives
  • Product Evolution, Site Transfers, and Continuous Improvement: Streamlining CMC Post-approval Changes globally
  • CMC Acceleration Strategies: Legislative pathways, regulatory flexibility, and pilots that enable faster development while maintaining quality and safety
  • Quality Maturity Management (QMM) and Evolving Global PQS Assessment Frameworks: Insights into programs supporting evolution of quality systems, promotion of quality culture, and opportunities to streamline regulatory pathways and mitigate supply chain risk
  • Platform Technology and Prior Knowledge: Progress toward a global understanding of opportunities and challenges with an emphasis on real world examples
  • Balancing Speed to Patient and Risk: CMC development strategies and regulatory frameworks that ensure optimal benefit-risk profile for clinical start and marketing approval
Key Questions to be Addressed
  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?
  5. How can we advance global regulatory harmonization and convergence to support supply chain stability and enhance product quality?
  6. How can science- and risk-based approaches better support overall pharmaceutical quality?
  7. How can product development teams effectively and reliably build a regulatory strategy around a foundation of prior knowledge and ensure confidence from global regulators?
  8. How can industry and regulators establish an optimal approach to efficiently evaluate investigational products by addressing CMC barriers that do not significantly impact patient benefit-risk profiles?

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