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11:00am • A Regulator's View on the Future Vision for Pharmacovigilance
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11:00am • Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
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11:00am • Advancing Innovation through Essential Drug Delivery Design Outputs
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11:00am • From Approval to Access: Integrating Patient Insights into Coverage Decisions
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11:00am • Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation
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11:00am • Is Real-World Evidence Always a Last Resort?
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11:00am • Project Orbis: Six Years Later
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11:00am • The Role of Identification of Medicinal Products in the Future of Global Healthcare
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11:00am • Moving Toward Pragmatism in Clinical Trials
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11:00am • Advancing Clinical Outcomes through Digital Health Technology Innovation
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2:15pm • Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
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2:15pm • Ushering in a New Era of Africa Healthcare
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2:15pm • Models of Collaborations to Advance Regulatory Science: Lessons Learned
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2:15pm • FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?
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2:15pm • Expanding Basket Trials to Cell and Gene Therapies for Rare Diseases
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2:15pm • Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
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2:15pm • Health Canada Town Hall
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2:15pm • A Masterclass: Patient Recruitment Campaign Management
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2:15pm • International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here
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2:15pm • Divergent Regulations and a Call for Regulatory Harmonization
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2:15pm • Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
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2:15pm • Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
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2:15pm • Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
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2:15pm • Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
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2:15pm • Building a Regulatory Landscape to Support CMC Innovation
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3:45pm • AI in Patient Care: Aspirations and Considerations
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3:45pm • Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
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3:45pm • Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
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3:45pm • Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication
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3:45pm • Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management
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3:45pm • Ethics in the Era of Precision Medicine and Advancing Technologies
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3:45pm • Efficient Data Exchange: Drivers for End-to-End Standards Adoption
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3:45pm • Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
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3:45pm • Generative Intelligence in Regulatory Affairs: A Journey of Industry Implementation
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3:45pm • Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
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3:45pm • Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
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3:45pm • Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
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3:45pm • Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
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3:45pm • WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation
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3:45pm • How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
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3:45pm • FDA Accelerated Approval Program: Putting Withdrawals in Context
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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
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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?
