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DIA 2027 · San Diego, CA

Track 9: R&D Quality and Compliance

This track explores the evolving landscape of quality and compliance across research and development, emphasizing proactive, risk-based approaches that ensure trial integrity, participant protections, and regulatory compliance across clinical trials, including agile, pragmatic, decentralized, and technology-enabled trial settings. Sessions highlight inspection readiness, global regulatory collaboration, and practical applications of GCP, GVP, GLP, ISO 14155, ICH E6(R3), and ICH E8(R1); foster a culture of quality; strengthen data governance and data reliability; address quality during organizational change; and leverage emerging technologies, including AI/ML, to enhance quality oversight.

Themes

Regulatory and Compliance

  • Inspection Findings: Health Authority trends and findings across GCP, GVP, and medical devices, and emerging inspection approaches, including FDA Remote Regulatory Assessments (RRAs) and Remote Interactive Evaluations (RIEs)
  • International Collaboration: Implementing ICH E6(R3) and advancing global collaboration while navigating regulatory harmonization and regional divergence
  • Organizational Structures: Understanding the functions and operations of regulatory authorities, including FDA, MHRA, and other global agencies

Operations, Change, and Technology

  • Mergers and Acquisitions (M&A): Addressing quality considerations during M&A, including due diligence, risk assessment, knowledge retention, and asset handover
  • Operationalizing ICH E6(R3) and ICH E8(R1): Applying Quality by Design (QbD), Risk-Based Quality Management (RBQM), data governance, transparency, and a culture of quality
  • Real World Evidence: Preparing registry and real-world data for inspection based on intended use and regulatory expectations
  • Artificial Intelligence: Leveraging AI/ML to safeguard critical-to-quality (CtQ) factors and strengthen quality management practices
  • AI Governance and Assurance: Ensuring AI/ML is fit for purpose through governance frameworks, audits, inspection findings, trends, and continuous improvement
  • Optimizing Data Quality: Strengthening data reliability in pragmatic, decentralized, and technology-enabled clinical trials
    • Key Questions to be Addressed
    1. How can organizations strengthen quality systems and risk-based approaches to improve trial integrity, participant protections, and regulatory compliance across increasingly complex clinical trials?
    2. How are evolving regulations, inspection findings, and global harmonization efforts shaping quality and compliance practices across GCP, GVP, GLP, ISO 14155, and medical devices?
    3. How can organizations leverage AI/ML, Quality by Design, Risk-Based Quality Management, and data governance to enhance quality oversight while ensuring inspection readiness and regulatory compliance?
    4. What operational strategies best support quality and compliance during organizational change, real-world evidence generation, decentralized and technology-enabled clinical trials, and other evolving research environments?

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