This track explores the evolving landscape of quality and compliance across research and development, emphasizing proactive, risk-based approaches to ensure trial integrity, participant protections, and regulatory compliance in clinical trials, including in agile, pragmatic, decentralized, and technology-enabled clinical trial settings. Sessions focus on practical applications of GCP, GVP, GLP, and ISO 14155 standards, fostering a culture of quality, strengthening data governance, and leveraging emerging technologies, including AI/ML, to enhance quality oversight across clinical trials and pharmacovigilance activities throughout the product lifecycle.

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