12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration 1:00pm - 4:00pm
21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol 9:30am - 12:30pm
22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development 1:00pm - 4:00pm
31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations 9:30am - 12:30pm
32P: Introduction to Artificial intelligence (AI) Regulations and Governance for Life Sciences 1:00pm - 4:00pm
41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials 9:30am - 12:30pm
42P: Regulatory Strategy Development for Complex Devices and Combination Products 1:00pm - 4:00pm
61F: Root Cause Analysis and CAPA Management: Your Essential Toolkit for Best Practices 9:00am - 5:00pm
62F: Electronic Patient-Reported Outcomes (ePRO): An Implementation Masterclass 9:00am - 5:00pm
A Regulator's View on the Future Vision for Pharmacovigilance 11:00am - 12:00pm
Why do Good Clinical Practice Inspectors Do Things Differently a... 11:00am - 12:00pm
Advancing Innovation through Essential Drug Delivery Design Outp... 11:00am - 12:00pm
From Approval to Access: Integrating Patient Insights into Cover... 11:00am - 12:00pm
Unintended Consequences: Effects of Inflation Reduction Act on t... 11:00am - 12:00pm
Is Real-World Evidence Always a Last Resort? 11:00am - 12:00pm
Project Orbis: Six Years Later 11:00am - 12:00pm
The Role of Identification of Medicinal Products in the Future o... 11:00am - 12:00pm
Moving Toward Pragmatism in Clinical Trials 11:00am - 12:00pm
Advancing Clinical Outcomes through Digital Health Technology In... 11:00am - 12:00pm
Innovation at the Intersection: Clinical Operations, Data Manage... 2:15pm - 3:15pm
Ushering in a New Era of Africa Healthcare 2:15pm - 3:15pm
Models of Collaborations to Advance Regulatory Science: Lessons... 2:15pm - 3:15pm
FDA Legislation 2025: How is Congress Preparing to Advance Innov... 2:15pm - 3:15pm
Expanding Basket Trials to Cell and Gene Therapies for Rare Dise... 2:15pm - 3:15pm
Clinical Care vs Research: Walking the Ethical Tightrope Between... 2:15pm - 3:15pm
Health Canada Town Hall 2:15pm - 3:15pm
A Masterclass: Patient Recruitment Campaign Management 2:15pm - 3:15pm
International Regulatory Harmonization for Development of Medici... 2:15pm - 3:15pm
Divergent Regulations and a Call for Regulatory Harmonization 2:15pm - 3:15pm
Leveraging the Capabilities of Artificial Intelligence and Digit... 2:15pm - 3:15pm
Tech-Enabled Clinical Development: Public Sector Innovation Lead... 2:15pm - 3:15pm
Setting the Bar High: Facilitating Quality and Acceptability of... 2:15pm - 3:15pm
Harnessing the Power of Generative AI: From Prompt Engineering t... 2:15pm - 3:15pm
Building a Regulatory Landscape to Support CMC Innovation 2:15pm - 3:15pm
AI in Patient Care: Aspirations and Considerations 3:45pm - 4:45pm
Applying Principles of Global Regulatory Collaboration to Addres... 3:45pm - 4:45pm
Enhancing Evidence Generation Across Pharmaceutical Life Cycle:... 3:45pm - 4:45pm
Mastering the Power of Words: Elevate Performance and Compliance... 3:45pm - 4:45pm
Spinning Plates and Juggling Chainsaws: Mastering the Art of Com... 3:45pm - 4:45pm
Ethics in the Era of Precision Medicine and Advancing Technologi... 3:45pm - 4:45pm
Efficient Data Exchange: Drivers for End-to-End Standards Adopti... 3:45pm - 4:45pm
Integrating Clinical Trials and Clinical Care: The Who, What, Wh... 3:45pm - 4:45pm
Generative Intelligence in Regulatory Affairs: A Journey of Indu... 3:45pm - 4:45pm
Advances in Clinical Trial Linkage to Real-World Data: Bridging... 3:45pm - 4:45pm
Prior Knowledge - How Experience of the Past Can Drive the Futur... 3:45pm - 4:45pm
Unlocking the Future of Clinical Trials: How the ICH M11 Digital... 3:45pm - 4:45pm
Pharmacovigilance: Beyond Signal Detection and Spontaneous Repor... 3:45pm - 4:45pm
WHO Town Hall: Driving Innovation and Access - Global Collaborat... 3:45pm - 4:45pm
How Soon is Too Soon? Enhancing Early Regulatory Engagement and... 3:45pm - 4:45pm
FDA Accelerated Approval Program: Putting Withdrawals in Context 3:45pm - 4:45pm
Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Q... 8:30am - 9:30am
Innovations in Signal Detection: Advancing Safety Signals with t... 8:30am - 9:30am
Diversity Action Plans in Rare Genetic Disease Drug Development:... 8:30am - 9:30am
Revolutionizing Medical Writing: Evaluating and Building the Ass... 8:30am - 9:30am
Real-World Data Traceability: Challenges and Solutions When Gene... 8:30am - 9:30am
International Harmonization in Real-World Evidence: Recent Effor... 8:30am - 9:30am
Realizing Value Through Responsible AI in Clinical Trials 8:30am - 9:30am
From Measuring to Modeling the Patient Burden: An Interactive Ta... 8:30am - 9:30am
Redesigning Research and Development Policies with Women in Mind... 8:30am - 9:30am
Japan Town Hall 8:30am - 9:30am
Innovative Regulatory Approaches for Developing Diagnostic Tests... 10:30am - 11:30am
US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rar... 10:30am - 11:30am
The Need for a Multi-Stakeholder Collaboration to Modernize ICSR... 10:30am - 11:30am
Case Studies of Application of AI in Risk-Based Quality Manageme... 10:30am - 11:30am
Enhancing Sustained Diversity in Clinical Trials: A New Framewor... 10:30am - 11:30am
ANVISA Town Hall 10:30am - 11:30am
Resilient Leadership: Overcoming Isolation and Adversity 10:30am - 11:30am
The Globalization of Risk Management 10:30am - 11:30am
Pathways to Innovation: Navigating Regulatory Expectations for A... 10:30am - 11:30am
Participant Compensation in Clinical Trials: Exploring Today’s L... 10:30am - 11:30am
FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Eff... 10:30am - 11:30am
Advancing a Global Regulatory Approach to Pharmaceutical Quality... 10:30am - 11:30am
Transforming the Project Management Role to Meet the Emerging Ne... 10:30am - 11:30am
Banishing Burnout: A Practice of Mindfulness Tools to Reduce Str... 10:30am - 11:30am
Innovation Reimagined: How Intelligent Automation is Redefining... 10:30am - 11:30am
Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evi... 10:30am - 11:30am
Forging a New Framework for Strategic Project Delivery: The Dyna... 1:45pm - 2:45pm
Reliable AI in Biomedical Settings: A Framework for Trust and In... 1:45pm - 2:45pm
Pediatric Cluster Town Hall 1:45pm - 2:45pm
Embracing ICH E6(R3) with Risk-Based Quality Management and Data... 1:45pm - 2:45pm
Updating Ethics: What’s New (and why it Matters!) in the 2024 De... 1:45pm - 2:45pm
Harmonizing Data Quality Frameworks: Bridging Regulatory Perspec... 1:45pm - 2:45pm
Charting New Courses: Reshaping Opportunities and Breaking the E... 1:45pm - 2:45pm
Statistical Challenges and Innovations in Small-Sized Clinical T... 1:45pm - 2:45pm
Has Decentralized Trials Crashed, or Are We Just Getting Started... 1:45pm - 2:45pm
Harnessing Opportunities Through Inspection Reliance: A Path to... 1:45pm - 2:45pm
The Adoption of Artificial Intelligence and Machine Learning in... 1:45pm - 2:45pm
Addressing Participation Burden in Clinical Trials: Evidence, Pa... 1:45pm - 2:45pm
Real-World Evidence to Optimize Risk Minimization Programs: How... 1:45pm - 2:45pm
The Laboratory-Developed Tests Final Rule: New Developments and... 1:45pm - 2:45pm
China Town Hall 1:45pm - 2:45pm
How Medical Writing Can Support Accelerating the Development of... 1:45pm - 2:45pm
Overcoming Site Burden: Driving Adoption of Automation and End-t... 4:00pm - 5:00pm
Delivering Effective Business Transformations and How to Apply t... 4:00pm - 5:00pm
How Do We Get from Here to There: Putting Real-World Data Qualit... 4:00pm - 5:00pm
Breaking Barriers: Making Health Information Accessible to All 4:00pm - 5:00pm
Global Collaborative Review: Understanding Overall Control Strat... 4:00pm - 5:00pm
Pharmacovigilance Inspector Fireside Chat 4:00pm - 5:00pm
Patient Engagement in Trial Design and the Evolving Landscape of... 4:00pm - 5:00pm
Enhancing Global Access to Innovative Therapies: Regulatory Conv... 4:00pm - 5:00pm
Using Generative AI to Explore our Track Record on Paying Partic... 4:00pm - 5:00pm
Externally Controlled Trials in Clinical Development: Challenges... 4:00pm - 5:00pm
Enhancing the Integration of Patient Experience in Assessing Tre... 4:00pm - 5:00pm
Advancing Premarketing Safety Analytics through FDA and Industry... 4:00pm - 5:00pm
Exploring Regulator Career Paths: The Impact of Diversity on Dec... 4:00pm - 5:00pm
Opportunities for Innovation Under Fragmented Regulatory Framewo... 4:00pm - 5:00pm
Updated Tufts Center for the Study of Drug Development Benchmark... 4:00pm - 5:00pm
Getting the Work of Medicines Development and Manufacturing Done... 4:00pm - 5:00pm
Expanding Research Participation through Local Health Care Provi... 8:30am - 9:30am
Rare but Real: Navigating Rare Disease Product Development and M... 8:30am - 9:30am
Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report 8:30am - 9:30pm
Transforming the Protocol from a Document-Centric to a Data-Cent... 8:30am - 9:30am
Electronic Submission of Safety Reports using E2B R3 standard -... 8:30am - 9:30am
Tackling Fraud and Misconduct in Clinical Trials: Regulatory and... 8:30am - 9:30am
How to Reduce Post-Approval Changes Complexity Through Agile Reg... 8:30am - 9:30am
From Bedside to Bench to Bedside: How Adverse Events Converge Cl... 8:30am - 9:30am
Clinical Trial Innovation at Scale: Opportunities to Increase Ad... 10:30am - 11:30am
Partnerships and Collaboration: How to Drive Clinical Trial Succ... 10:30am - 11:30am
Leveraging AI and Structured Content Authoring Tools in Regulato... 10:30am - 11:30am
Why Patient Involvement is a Must Have to Ensure Accessibility t... 10:30am - 11:30am
Practical Implementation of MRCTs Based on ICH E17 Guidelines 10:30am - 11:30am
Leader Effectiveness: Inclusive Leadership Practices to Improve... 10:30am - 11:30am
Quality Oversight: Enhancing Approaches Across Organizations to... 10:30am - 11:30am
From Guidelines to Real-World Impact: Considerations for the Pra... 10:30am - 11:30am
Artificial Intelligence in the Medicines Lifecycle: Delivering G... 10:30am - 11:30am
Patient Referral: Is It Hope or Hype? 10:30am - 11:30am
Do Flexible Trial Approaches Impede Data Quality? Perception vs... 10:30am - 11:30am
Trustworthy AI Solutions for Next-Generation Pharmacovigilance 10:30am - 11:30am
Why Does Drug Loss Occur? Challenges to be Addressed for Patient... 10:30am - 11:30am
Navigating the Challenges of Drug Delivery Using a Novel Device 10:30am - 11:30am
Regulatory and HTA Considerations When Using External Evidence t... 10:30am - 11:30am
Research in Participants with Progressive Cognitive Impairment:... 10:30am - 11:30am
Post-Marketing Safety Management in Asia Using Real-World Data:... 1:45pm - 2:45pm
EMA Town Hall 1:45pm - 2:45pm
Clinical Development of Orphan and Pediatric Drugs, Along with R... 1:45pm - 2:45pm
Portfolio Management in Pharma: Strategies and Insights from Lar... 1:45pm - 2:45pm
AI, Virtual Control Groups, and Organoids: How New Technologies... 1:45pm - 2:45pm
Innovative Operating Models in Regulatory Affairs Driving Value,... 1:45pm - 2:45pm
Potency Measurements for Cellular and Gene Therapy Products 1:45pm - 2:45pm
Africa's Evolving Regulatory Landscape 1:45pm - 2:45pm
Unleash the Potential of Synthetic Data and Digital Twins Using... 1:45pm - 2:45pm
ICH Pharmaceutical Quality Knowledge Management Platform Global... 1:45pm - 2:45pm
Transforming Industry through Mentorship 1:45pm - 2:45pm
Techquity in Digital Trials: Tech, Data, and Operationalizing Eq... 1:45pm - 2:45pm
Addressing Challenges in Devices Safety Monitoring 1:45pm - 2:45pm
Evolving Regulatory Considerations for Medical Affairs Communica... 1:45pm - 2:45pm
Pharmacovigilance Inspections: How Do Inspectors Decide Where an... 1:45pm - 2:45pm
Workshop: AI in Healthcare (Industry and Regulators) 2:45pm - 3:45pm
Modernizing Evidence in Oncology: Real World Data and Artificial... 4:00pm - 5:00pm
International Regulatory Engagement for Advancing Regulatory Sci... 4:00pm - 5:00pm
Considerations for Adaptive Design Using Bayesian Methods: An Up... 4:00pm - 5:00pm
Quality Briefs from Inception to Operationalization: How to Enga... 4:00pm - 5:00pm
Beyond Weight Loss: Pioneering the Future of Obesity Drug Develo... 4:00pm - 5:00pm
Privacy-Preserving Data Access and Collaboration for RWE Generat... 4:00pm - 5:00pm
Examining Bias in Lung Cancer Study Protocols: Lessons Learned 4:00pm - 5:00pm
Beyond Clinical-Outcome Assessments: Best Practices for Submitti... 4:00pm - 5:00pm
Enhancing Pharmacovigilance and Reducing Medication Errors by Ap... 4:00pm - 5:00pm
Successful Patient Input to Regulatory and Health Technology Ass... 4:00pm - 5:00pm
Business Agility: Applying Strategic and Critical Thinking to Re... 4:00pm - 5:00pm
Regulatory Perspectives on the Adoption of Advanced Manufacturin... 4:00pm - 5:00pm
FDA Rare Disease Town Hall 4:00pm - 5:00pm
Collaborating for Equity: The FDA OMHHE REACH Consortium's Partn... 4:00pm - 5:00pm
Cutting Through the Hype: How are AI and Emerging Technologies A... 4:00pm - 5:00pm
Quality Risk Management for a Decentralized/Hybrid Clinical Tria... 9:00am - 10:00am
EMA - FDA Question Time 9:00am - 10:00am
Bridging Science and Business: A Roadmap from Pharmaceutical Res... 9:00am - 10:00am
Implementing the Aggregate Safety Assessment Planning and Aggreg... 9:00am - 10:00am
How AI is Transforming the Area of Data Standards and Access to... 9:00am - 10:00am
Embedding and Leveraging AI for Quality and Compliance in Pharma 9:00am - 10:00am
Beyond the Frequentist Approach in Hard to Recruit Populations:... 9:00am - 10:00am
FDA Town Hall 10:30am - 12:00pm
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