Conference Designed For:

• Academia
• Advocacy and Service Provider Professionals
• Biopharma/Medical Device Industry
• Clinical Research
• Data analytics
• Epidemiology
• Health Authority
• Health Economics and Outcomes Research
• Payer
• Pharmacovigilance
• Policy
• Real-World Evidence
• Real-World Data
• Regulatory Science
• Technology Development

At the completion of this conference, the participant should be able to:

• List recent global regulatory updates on RWE from EMA, FDA, and ICH, including new guidances, DARWIN EU progress, and the evolving M14 standard
• Discuss lessons from regulatory inspections and international registry case studies on data quality, transparency, and integrity
• Describe innovative trial designs that integrate real-world data with randomized studies to address evidence gaps
• Examine the use of synthetic data for research in hard-to-reach populations and sensitive therapeutic areas
• Outline evolving standards for peer-reviewed publications and how global OMOP collaborations are advancing regulatory-grade evidence generation
• Discuss evolving standards for peer-reviewed publications and how global OMOP collaborations are advancing regulatory-grade evidence generation
• Explain how artificial intelligence and machine learning are transforming RWE applications in patient journey insights, pharmacovigilance, and trial feasibility
• Summarize emerging policy priorities and cross-stakeholder collaborations shaping the next generation of RWE frameworks