Agenda

Day 1 Jun 17, 2024

11:00 AM — 12:00 PM

China Town Hall

11:00 AM — 12:00 PM

Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update

2:15 PM — 3:15 PM

Comparative Perspectives on Regulating AI in Drug Development: US Versus EU

2:15 PM — 3:15 PM

The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA

3:30 PM — 4:30 PM

Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking

3:30 PM — 4:30 PM

Health Canada Town Hall

3:30 PM — 4:30 PM

Impact of Accelerated Pathways on Patients in Five Countries/Regions

Day 2 Jun 18, 2024

8:00 AM — 9:00 AM

Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability

8:00 AM — 9:00 AM

Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT

8:00 AM — 9:00 AM

PMDA Town Hall

10:00 AM — 11:00 AM

Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement

1:15 PM — 2:15 PM

FDA Rare Disease Town Hall

1:15 PM — 2:15 PM

Platform Technology Designation: Opportunities and Challenges for Implementation

3:15 PM — 4:15 PM

How to Provide Necessary Medicinal Products to Children?

3:15 PM — 4:15 PM

Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines

3:15 PM — 4:15 PM

This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice

4:30 PM — 5:30 PM

ANVISA Town Hall

4:30 PM — 5:30 PM

Recent Evolution of the Accelerated Approval Pathway: Impacts on Use and Implementation

4:30 PM — 5:30 PM

Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox

Day 3 Jun 19, 2024

8:00 AM — 9:00 AM

Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration

8:00 AM — 9:00 AM

FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”

8:00 AM — 9:00 AM

WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence

10:00 AM — 11:00 AM

A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?

10:00 AM — 11:00 AM

Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products

1:15 PM — 2:15 PM

Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA)

1:15 PM — 2:15 PM

ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance

1:15 PM — 2:15 PM

ICMRA Post-Pandemic: Regulators Looking into the Future

3:15 PM — 4:15 PM

EMA Town Hall

3:15 PM — 4:15 PM

Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?

3:15 PM — 4:15 PM

The Intersection of Patient-Experience Data and Benefit-Risk Analysis

4:30 PM — 5:30 PM

Middle East and Africa: Emerging Opportunities

4:30 PM — 5:30 PM

Sustainability of Rare Disease Drug Development

4:30 PM — 5:30 PM

Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation

Day 4 Jun 20, 2024

8:00 AM — 9:00 AM

More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier

8:00 AM — 9:00 AM

The FDA's Commitment to Patient-Centric Research: Key Themes from Decentralized Trial Draft Guidance

9:15 AM — 10:15 AM

Regulatory Affairs of the Future: Is Now

9:15 AM — 10:15 AM

What is the Value of Reference Agency Assessment Reports in Enabling Reliance and What do Relying Agencies Require?

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DIA 2024 Global Annual Meeting

Agenda

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