DIA 2024 Global Annual Meeting

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DIA 2024 Global Annual Meeting

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11:00am PDT

#104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards Room 15AB #106: Machine Learning and Simulations to Facilitate Clinical Trials Room 5AB #105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development Room 17AB #109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US? Room 1AB

2:15pm PDT

#132: The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing Room 5AB #133: ICH M11 Protocol Template: A Global Solution for Global Drug Development Room 17AB #131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation Room 14AB #134: Shifting Medical Writing Value Propositions with the Use of Technology Tools Room 2 #138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective Room 6D #139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU Room 6C #137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines Room 1AB #136: In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs Room 15AB #141: Innovation in Manufacturing Globally Room 11AB #142: Causal Inference Methodology in Drug Development Room 6E

3:30pm PDT

#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward Room 6C #145: Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs Room 5AB #148: Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents Room 7AB #152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond Room 17AB #153: Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking Room 15AB #154: Impact of Accelerated Pathways on Patients in Five Countries/Regions Room 11AB #155: Health Canada Town Hall Room 6D #156: Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission Room 6E #151: Elevate Leadership: Harnessing the Five Superpowers Room 2