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8:30am • Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities
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8:30am • Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
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8:30am • Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
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8:30am • Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Efficiencies and Regulatory Review
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8:30am • Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
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8:30am • Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
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8:30am • How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
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8:30am • From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
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10:30am • Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance
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10:30am • Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa
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10:30am • Leveraging AI and Structured Content Authoring Tools in Regulatory Medical Writing: A 1-Year Look
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10:30am • Why Patient Involvement is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
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10:30am • Practical Implementation of MRCTs Based on ICH E17 Guidelines
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10:30am • Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
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10:30am • Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
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10:30am • From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
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10:30am • Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
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10:30am • Patient Referral: Is It Hope or Hype?
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10:30am • Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
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10:30am • Trustworthy AI Solutions for Next-Generation Pharmacovigilance
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10:30am • Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development
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10:30am • Navigating the Challenges of Drug Delivery Using a Novel Device
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10:30am • Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
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10:30am • Research in Participants with Progressive Cognitive Impairment: Best practices for ensuring continuing informed consent
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1:45pm • Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe
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1:45pm • EMA Town Hall
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1:45pm • Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
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1:45pm • Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations
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1:45pm • AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
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1:45pm • Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
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1:45pm • Potency Measurements for Cellular and Gene Therapy Products
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1:45pm • Africa's Evolving Regulatory Landscape
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1:45pm • Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Medical Product Development
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1:45pm • ICH Pharmaceutical Quality Knowledge Management Platform Global Regulatory Assessment and Industry-Vision to Reality
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1:45pm • Transforming Industry through Mentorship
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1:45pm • Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research
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1:45pm • Addressing Challenges in Devices Safety Monitoring
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1:45pm • Evolving Regulatory Considerations for Medical Affairs Communications
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1:45pm • Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
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2:45pm • Workshop: AI in Healthcare (Industry and Regulators)
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4:00pm • Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development
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4:00pm • International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs
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4:00pm • Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
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4:00pm • Quality Briefs from Inception to Operationalization: How to Engage Internal Stakeholders
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4:00pm • Beyond Weight Loss: Pioneering the Future of Obesity Drug Development
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4:00pm • Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges
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4:00pm • Examining Bias in Lung Cancer Study Protocols: Lessons Learned
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4:00pm • Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators
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4:00pm • Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
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4:00pm • Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact
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4:00pm • Business Agility: Applying Strategic and Critical Thinking to Recognize Global Business Environment and Adopt Strategies
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4:00pm • Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies
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4:00pm • FDA Rare Disease Town Hall
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4:00pm • Collaborating for Equity: The FDA OMHHE REACH Consortium's Partnership with Federally Qualified Health Centers and Community Health Workers
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4:00pm • Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
