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Type: 09: Regulatory, Forum clear filter
Monday, June 16
 

11:00am EDT

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

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 Best Practices for Navigating Divergent Regulatory Feedback TBD

3:45pm EDT

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation TBD
 
Tuesday, June 17
 

8:30am EDT

Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence TBD

1:45pm EDT

Pediatric Cluster Town Hall TBD

4:00pm EDT

Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics TBD
 
Wednesday, June 18
 

8:30am EDT

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

10:30am EDT

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

1:45pm EDT

Indonesia Town Hall TBD Evolving Regulatory Considerations for Medical Affairs Communications 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 Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators TBD
 
Thursday, June 19
 

9:00am EDT

EMA - FDA Question Time TBD

10:30am EDT

FDA Town Hall TBD
 
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