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8:30am • Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards
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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 • 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 Automation and Regulatory Review
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8:30am • Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
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8:30am • Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
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8:30am • The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways
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8:30am • Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum
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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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9:45am • IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness
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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 • Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing
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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 • Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent
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10:30am • Why Patient/Site Collaboration is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
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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 • Practical Implementation of MRCTs Based on ICH E17 Guidelines
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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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12:00pm • Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects
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12:00pm • Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
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12:00pm • Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
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12:20pm • CH: Addressing Key Challenges in Global Biosimilar Development and Regulation
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1:00pm • CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?
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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 • 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 • Indonesia Town Hall
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1:45pm • Africa's Evolving Regulatory Landscape
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1:45pm • EMA Town Hall
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1:45pm • Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development
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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 • Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation
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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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2:55pm • Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
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2:55pm • Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability
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2:55pm • Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
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3:00pm • CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out
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4:00pm • Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders
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4:00pm • Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability
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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 • Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders
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4:00pm • Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
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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 • Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers
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4:00pm • Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations
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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 • 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 • Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
