Agenda
9:30 AM — 12:30 PM
Aggregate Safety Assessment Planning Process8:00 AM — 10:00 AM
Hidden Potential: Turning Today’s Science into Tomorrow’s Cures11:00 AM — 12:15 PM
Combined Clinical Trials: A Focus on In Vitro Diagnostics11:00 AM — 12:15 PM
Enhancing Regulatory Collaboration through Cloud Technologies11:00 AM — 12:15 PM
Evidence-Based Insights Informing Participant Compensation Strategies11:00 AM — 12:15 PM
Health Canada Town Hall11:00 AM — 12:15 PM
Regulatory Cooperation Between the United States and Japan11:00 AM — 12:15 PM
The Great Debate: Using AI in Patient-Facing Materials2:30 PM — 3:30 PM
A Conversation about Quality: A Global Regulators Discussion2:30 PM — 3:30 PM
Driving Efficiency in Clinical Development with Master Protocols2:30 PM — 3:30 PM
Industry Collaboration 2030: Head, Heart and Gut Perspectives4:00 PM — 5:00 PM
DIA2026-001: Co-Creating the Patient-Centric Trial Live4:00 PM — 5:00 PM
Japan Town Hall4:00 PM — 5:00 PM
Medical Writing Ted Experience4:00 PM — 5:00 PM
Mentorship Myth Busters: Moving Beyond Misconceptions4:00 PM — 5:00 PM
Understanding the Misconceptions and Myths around Surrogate Endpoints10:15 AM — 11:30 AM
AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate10:15 AM — 11:30 AM
Before You Build: Finding Real Product–Market Fit in Clintech and Biotech10:15 AM — 11:30 AM
From Barriers to Bridges: Unlocking Research Potential in Primary Care10:15 AM — 11:30 AM
Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients10:15 AM — 11:30 AM
Next Generation Clinical Trial Quality Assurance Using Advanced Analytics10:15 AM — 11:30 AM
Patient Registries: Basket Trial or Basket Case?1:45 PM — 3:00 PM
Innovations in Drug Review1:45 PM — 3:00 PM
Regulators Approach to Address Drug Shortages1:45 PM — 3:00 PM
Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention1:45 PM — 3:00 PM
Unlock AI's Full Potential: The Power of FAIR Data4:15 PM — 5:15 PM
China Town Hall4:15 PM — 5:15 PM
Reverse Pitches: How Pharma Actually Buys10:15 AM — 11:30 AM
Can You Complete Your Submission in 10 weeks?10:15 AM — 11:30 AM
Counting the Cost: Translating Participant Burden into Fair Compensation10:15 AM — 11:30 AM
Decision Under Uncertainty10:15 AM — 11:30 AM
FDA Rare Disease Town Hall10:15 AM — 11:30 AM
International Regulatory Cooperation with the African Medicines Agency10:15 AM — 11:30 AM
Streamlined Trials Embedded in Pragmatic Settings1:45 PM — 2:45 PM
Bold Leadership: Embolden Your Team for Smart Risk-Taking1:45 PM — 2:45 PM
Designing the Future: Emulation of Clinical Trials Using Real-World Data1:45 PM — 2:45 PM
Destigmatizing 483 Observations1:45 PM — 2:45 PM
Program Manager: Jack of All Trades, Master of None?4:00 PM — 5:00 PM
50,000 Participants, Two Countries, One DCT: Oversight That Worked4:00 PM — 5:00 PM
Navigating the New FDA: Insights from Former FDA Chief of Staffs4:00 PM — 5:00 PM
Regulatory CMC and Product Quality Hot Topics Discussion4:00 PM — 5:00 PM
The New Era for Innovation: Catalysts and Collaborators for Acceleration8:00 AM — 9:00 AM
Fighting Medical Disinformation (Without Actually Starting a Fight)8:00 AM — 9:00 AM
No Report Left Behind: Human-Centered Safety Reporting8:00 AM — 9:00 AM
The View from the Top: What is the Future of Medical Writing?Have an account?