DIA 2024 Global Annual Meeting

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DIA 2024 Global Annual Meeting

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8:00am PDT

#302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics Room 6A #309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?” Room 6F #310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence Room 1AB #311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration Room 6B #307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products Room 2

10:00am PDT

#326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products Room 6C #328: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products Room 6A #325: A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived? Room 11AB

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle Ballroom 20 A/ Zone 1 #330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation Ballroom 20 BC/ Zone 2

1:15pm PDT

#345: Regulatory Considerations in Trial Design for Cell and Gene Therapies Room 5AB #352: Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA) Room 6F #353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance Room 16AB #354: ICMRA Post-Pandemic: Regulators Looking into the Future Room 6A #349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates Room 15AB #347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations Room 6B #350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development Room 11AB

2:15pm PDT

#357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience Ballroom 20 BC/ Zone 2

3:15pm PDT

#366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis Room 5AB #365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going? Room 6F #367: EMA Town Hall Room 6A #363: Implementing Changes To Drug-Device Combination Products Globally Room 1AB

4:30pm PDT

#374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation Room 5AB #375.1: Middle East Emerging Opportunities Room 6C #375: Sustainability of Rare Disease Drug Development Room 6F #376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices Room 6E