DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

1:00pm EDT

12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration TBD

9:30am EDT

31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations TBD

1:00pm EDT

42P: Regulatory Strategy Development for Complex Devices and Combination Products TBD

11:00am EDT

Accelerating Global Access to Drugs for Chronic Diseases TBD Moving Toward Pragmatism in Clinical Trials TBD Project Orbis: Six Years Later TBD Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation TBD Advancing Innovation Through Essential Drug Delivery Outputs TBD Putting Patients First: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives TBD

12:50pm EDT

CH: Regulatory Intelligence to Drive Regulatory Strategy TBD

2:15pm EDT

FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding? TBD International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here TBD Health Canada Town Hall TBD Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence TBD Best Practices for Navigating Divergent Regulatory Feedback TBD

3:45pm EDT

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease TBD FDA Accelerated Approval Program: Putting Withdrawals in Context TBD Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation TBD WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation TBD Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders TBD Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management TBD AI in Patient Care: Aspirations and Considerations TBD

8:30am EDT

A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge TBD International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers TBD Japan Town Hall TBD MHRA Town Hall TBD Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence TBD

10:30am EDT

ANVISA Town Hall TBD Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development TBD US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases TBD Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence TBD

12:00pm EDT

Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease TBD

1:45pm EDT

Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives TBD Pediatric Cluster Town Hall TBD China Town Hall TBD

2:55pm EDT

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

4:00pm EDT

Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics TBD Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products TBD Towards Instantaneous Regulatory Decisions and Better Predictability TBD Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance TBD

8:30am EDT

Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum TBD Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards TBD The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways TBD

10:30am EDT

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance TBD Practical Implementation of MRCTs Based on ICH E17 Guidelines TBD Navigating the Challenges of Drug Delivery Using a Novel Device TBD

12:20pm EDT

CH: Addressing Key Challenges in Global Biosimilar Development and Regulation TBD

1:45pm EDT

Africa's Evolving Regulatory Landscape TBD EMA Town Hall TBD Indonesia Town Hall TBD Evolving Regulatory Considerations for Medical Affairs Communications TBD Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success TBD

2:55pm EDT

Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products TBD Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability TBD

4:00pm EDT

International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs TBD Beyond Weight Loss: Pioneering the Future of Obesity Drug Development TBD FDA Rare Disease Town Hall TBD Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20 TBD Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators TBD

9:00am EDT

EMA - FDA Question Time TBD

10:30am EDT

FDA Town Hall TBD

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