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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 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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Key Questions to be Addressed:
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Workshop on Automation and Artificial Intelligence in Signal Management
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Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies
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Basics of Signal Detection and Pharmacoepidemiology
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Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process
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Pharmacovigilance System Master File: How to Prepare and Maintain
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EudraVigilance Data Analysis System (EVDAS): Practical Approach on Use for Signal Management in the EU
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