In this session, learn how AI is advancing drug discovery and the development of medical devices, while reconciling legal and regulatory challenges across key markets. Topics of discussion will include:

• Highlighting how AI is revolutionizing drug discovery and the advancement of medical devices/diagnostics
• Regulatory pathways for AI-enabled medical devices
• Current regulatory framework under EU MDR
• Interactions with EU AI Act
• Comparative analysis – UK vs EU vs USA approaches
• Preparing for potential legal liabilities within AI-driven drug and device development:
• Innovation and IP
• Quality control and assurance
• Data integrity and privacy
• Accountability and transparency
• Regulatory approvals
• Best practices for life sciences companies to minimize legal risks and remain compliant
• Fueling AI with the Right Data: Identifying and accessing high-quality data sources for AI training
• The European Health Data Space (EHDS): Unlocking its potential as a key resource for AI development
• Balancing Innovation and Privacy: Overcoming challenges in AI training within the EHDS framework