DIA 2024 Global Annual Meeting

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DIA 2024 Global Annual Meeting

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8:00am PDT

#201: Considerations for Identification of Drug-Induced Liver Injury Room 6D #204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders Room 5AB #206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making Room 16AB #208: Good Data Governance Practices: Regulatory and Industry Perspectives Room 14AB #211: PMDA Town Hall Room 15AB #212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability Room 6F #213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications Room 17AB

10:00am PDT

#222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms Room 11AB #225: Regulatory Guidance and Papers on Technology Innovations Room 6D #227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective Room 17AB #228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement Room 16AB

1:15pm PDT

#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time Room 17AB #252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features Room 15AB #248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle Room 6F #249: Topics Related to the Oncology Real-Time Oncology Review Process Room 1AB #254: FDA Rare Disease Town Hall Room 6A #245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On Room 5AB

3:15pm PDT

#263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward Room 6B #270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management Room 8 #271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections? Room 16AB #272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice Room 6F #273: How to Provide Necessary Medicinal Products to Children? Room 17AB #267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare Room 11AB #275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation Room 6D

4:30pm PDT

#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data Room 11AB #278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy Room 6C #284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance Room 5AB #281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU Room 6B #279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials Room 6F #285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox Room 16AB #290: Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US Room 8 #283: The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies Room 2