Agenda

Day 1 Jun 16, 2025

11:00 AM — 12:00 PM

Moving Toward Pragmatism in Clinical Trials

11:00 AM — 12:00 PM

Project Orbis: Six Years Later

11:00 AM — 12:00 PM

Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation

2:15 PM — 3:15 PM

FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?

2:15 PM — 3:15 PM

Health Canada Town Hall

2:15 PM — 3:15 PM

International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here

3:45 PM — 4:45 PM

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

3:45 PM — 4:45 PM

FDA Accelerated Approval Program: Putting Withdrawals in Context

3:45 PM — 4:45 PM

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation

3:45 PM — 4:45 PM

WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation

Day 2 Jun 17, 2025

8:30 AM — 9:30 AM

A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge

8:30 AM — 9:30 AM

International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers

8:30 AM — 9:30 AM

Japan Town Hall

10:30 AM — 11:30 AM

ANVISA Town Hall

10:30 AM — 11:30 AM

Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development

10:30 AM — 11:30 AM

US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases

1:45 PM — 2:45 PM

China Town Hall

1:45 PM — 2:45 PM

Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives

1:45 PM — 2:45 PM

Pediatric Cluster Town Hall

4:00 PM — 5:00 PM

Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products

4:00 PM — 5:00 PM

Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance

4:00 PM — 5:00 PM

Towards Instantaneous Regulatory Decisions and Better Predictability

Day 3 Jun 18, 2025

8:30 AM — 9:30 AM

Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum

8:30 AM — 9:30 AM

Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards

8:30 AM — 9:30 AM

The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways

10:30 AM — 11:30 AM

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance

10:30 AM — 11:30 AM

Practical Implementation of MRCTs Based on ICH E17 Guidelines

1:45 PM — 2:45 PM

Africa's Evolving Regulatory Landscape

1:45 PM — 2:45 PM

EMA Town Hall

1:45 PM — 2:45 PM

Indonesia Town Hall

1:45 PM — 2:45 PM

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success

4:00 PM — 5:00 PM

Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators

4:00 PM — 5:00 PM

Beyond Weight Loss: Pioneering the Future of Obesity Drug Development

4:00 PM — 5:00 PM

FDA Rare Disease Town Hall

4:00 PM — 5:00 PM

International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs

Day 4 Jun 19, 2025

9:00 AM — 10:00 AM

EMA - FDA Question Time

10:30 AM — 12:00 PM

FDA Town Hall

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DIA 2025 Global Annual Meeting

Agenda

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