3rd America Drug Safety & AI 2025

3rd America Drug Safety & AI 2025 is organized by Why Summits? and will be held from Dec 09 - 10, 2025 in San Diego, California, United States of America.

What to Expect:
?AI is already used in pharmacovigilance, but discussions often remain surface-level. As validated tools emerge, the focus shifts from if to how – gaining competitive advantage, ensuring transparency, and extracting value from new technologies. Regulators like EMA and FDA offer guidance, yet challenges persist around validating learning systems, justifying AI-driven signals, and shaping regulations.

AI is also changing PV roles, requiring new skills and workforce retraining. Ethical concerns like bias and underrepresentation must be addressed. We invite you to explore these critical issues at the 3rd AMERICA DRUG SAFETY & AI 2025.

Main Takeaways:

• Enterprise-Level AI Strategies
• Cross-Departmental Data Integration for End-to-End Signal Detection
• Validation Frameworks for Adaptive AI/ML Models
• Regulatory Readiness for AI Outputs in Inspection Scenarios
• Digital Infrastructure for Scalable PV Automation
• Risk-Based Automation of ICSRs
• AI & RWE
• Cross-Validation Between Human and AI Decisions
• Strategies For AI Into Existing PV Frameworks
• Integration of AI Across Multi-Vendor PV Ecosystems
• Training and Upskilling the Legacy Workforce: Organizational Change Management
• Global Regulatory And Compliance Harmonization
• Harmonizing Global Data Standards for AI
• AI Governance Models for Safety Committees

Benefits of Attending:

• Forward-Looking Insights: Discover the latest trends, challenges, and advancements in pharmacovigilance from world-renowned industry leaders. Prepare for the future of drug safety with actionable strategies.
• Unparalleled Networking: Build connections with senior executives, regulatory specialists, and industry pioneers. Expand your professional network and collaborate with like-minded experts to drive innovation.
• Comprehensive Engagement: Participate in interactive discussions and hands-on sessions tackling key issues like emerging technologies, regulatory changes, and operational excellence, all led by top professionals.
• Global Expertise: Gain a worldwide perspective on the pharmacovigilance landscape, with insights into international regulations, diverse market environments, and strategies for effective global collaboration.
• Knowledge Exchange: Share experiences, learn best practices, and explore cutting-edge solutions to enhance your organization’s safety and compliance frameworks.