Agenda

Day 1 Jun 15, 2026

11:00 AM — 12:15 PM

FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis

11:00 AM — 12:15 PM

Health Canada Town Hall

11:00 AM — 12:15 PM

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

11:00 AM — 12:15 PM

Regulatory Cooperation Between the United States and Japan

11:00 AM — 12:15 PM

Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact

2:30 PM — 3:30 PM

A Conversation about Quality: A Global Regulators Discussion

2:30 PM — 3:30 PM

Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty

2:30 PM — 3:30 PM

Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines

2:30 PM — 3:30 PM

The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, PMDA, and CDE

4:00 PM — 5:00 PM

Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children

4:00 PM — 5:00 PM

Japan Town Hall

4:00 PM — 5:00 PM

Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities

4:00 PM — 5:00 PM

Understanding the Misconceptions and Myths around Surrogate Endpoints

Day 2 Jun 16, 2026

10:15 AM — 11:30 AM

Global Regulatory Perspectives on Obesity as a Chronic Disease: Learnings from FDA, EMA, PMDA, CDE, and Beyond

10:15 AM — 11:30 AM

Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients

10:15 AM — 11:30 AM

Leveraging Federated AI and Open Data to Transform Oncology Research and Development

10:15 AM — 11:30 AM

Modernizing Preclinical Testing: FDA and EMA Roadmaps for New Approach Methodologies

1:45 PM — 3:00 PM

Innovations in Drug Review

1:45 PM — 3:00 PM

Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication

1:45 PM — 3:00 PM

Regulators Approach to Address Drug Shortages

4:15 PM — 5:15 PM

Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation

4:15 PM — 5:15 PM

Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation

4:15 PM — 5:15 PM

China Town Hall

4:15 PM — 5:15 PM

Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment

Day 3 Jun 17, 2026

10:15 AM — 11:30 AM

FDA Rare Disease Town Hall

10:15 AM — 11:30 AM

International Regulatory Cooperation with the African Medicines Agency

10:15 AM — 11:30 AM

Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact

10:15 AM — 11:30 AM

Streamlined Trials Embedded in Pragmatic Settings

1:45 PM — 2:45 PM

Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes

1:45 PM — 2:45 PM

Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22

1:45 PM — 2:45 PM

The Next Frontier: Autoimmune Cell & Gene Therapy, Regulation, and Patient Access

4:00 PM — 5:00 PM

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle

4:00 PM — 5:00 PM

India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation

4:00 PM — 5:00 PM

Navigating the New FDA: Insights from Former FDA Chief of Staffs

4:00 PM — 5:00 PM

Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts

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DIA 2026 Global Annual Meeting

Agenda

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