Global Safety Data Sharing & Real-World Evidence Integration

Subhadip Jana, Sr. Director of Global Regulatory Affairs at ADC Therapeutics, presents a breakout session on global safety data sharing and the integration of real-world evidence into safety decision-making. As regulators worldwide increasingly demand real-world evidence to complement clinical trial data, safety organizations must develop new capabilities for collecting, analyzing, and sharing safety data across borders.

The session will explore emerging frameworks for international safety data sharing, including the challenges of data harmonization, privacy compliance across jurisdictions, and the technical infrastructure needed to enable real-time global safety intelligence. Subhadip will share practical examples of how organizations are integrating electronic health records, patient registries, and social media monitoring into their safety evidence base.

Attendees will gain insights into how to build a real-world evidence strategy for their safety organizations and navigate the regulatory and operational complexities of global data sharing.