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8:30am • Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective
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8:30am • Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates
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8:30am • Diversity Action Plans in Rare Genetic Disease Drug Development: Obstacles and Opportunities
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8:30am • Revolutionizing Medical Writing: Evaluating and Building the Assistive Technology Ecosystem
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8:30am • Real-World Data Traceability: Challenges and Solutions When Generating Regulatory-Grade Data
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8:30am • International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
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8:30am • Realizing Value Through Responsible AI in Clinical Trials
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8:30am • From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
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8:30am • Redesigning Research and Development Policies with Women in Mind: Turning Ambition to Impact
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8:30am • Japan Town Hall
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10:30am • Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
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10:30am • US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
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10:30am • The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
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10:30am • Case Studies of Application of AI in Risk-Based Quality Management
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10:30am • Enhancing Sustained Diversity in Clinical Trials: A New Framework and Case Study for Community-Centered Collaborations
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10:30am • ANVISA Town Hall
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10:30am • Resilient Leadership: Overcoming Isolation and Adversity
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10:30am • The Globalization of Risk Management
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10:30am • Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development
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10:30am • Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities
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10:30am • FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct
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10:30am • Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management
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10:30am • 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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10:30am • Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being
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10:30am • Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence
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10:30am • Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development
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1:45pm • Forging a New Framework for Strategic Project Delivery: The Dynamic Phased Delivery Model
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1:45pm • Reliable AI in Biomedical Settings: A Framework for Trust and Innovation in an Evolving Landscape
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1:45pm • Pediatric Cluster Town Hall
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1:45pm • Embracing ICH E6(R3) with Risk-Based Quality Management and Data Governance
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1:45pm • Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision
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1:45pm • Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
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1:45pm • Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development
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1:45pm • Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
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1:45pm • Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology
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1:45pm • Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
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1:45pm • The Adoption of Artificial Intelligence and Machine Learning in Clinical Research
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1:45pm • Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact
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1:45pm • Real-World Evidence to Optimize Risk Minimization Programs: How to Move from Art to Science
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1:45pm • The Laboratory-Developed Tests Final Rule: New Developments and Compliance Insights
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1:45pm • China Town Hall
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1:45pm • How Medical Writing Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot
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4:00pm • Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration
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4:00pm • Delivering Effective Business Transformations and How to Apply them to Drug Development
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4:00pm • How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice
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4:00pm • Breaking Barriers: Making Health Information Accessible to All
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4:00pm • Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
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4:00pm • Pharmacovigilance Inspector Fireside Chat
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4:00pm • Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
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4:00pm • Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
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4:00pm • Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation
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4:00pm • Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
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4:00pm • Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability
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4:00pm • Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
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4:00pm • Exploring Regulator Career Paths: The Impact of Diversity on Decision Making and Medicines Development
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4:00pm • Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development
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4:00pm • Updated Tufts Center for the Study of Drug Development Benchmarks on Vendor Qualification Practices: Insights from the Evolving Pharma Landscape
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4:00pm • Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work
