As Artificial Intelligence (AI) becomes increasingly embedded in clinical development and regulatory processes, global health authorities have responded with a range of evolving guidelines to ensure safety, transparency, data privacy, and compliance. From optimizing trial design and accelerating patient recruitment to generating insights in regulatory submissions, AI holds transformative potential but also introduces novel regulatory challenges.
In this session, we’ll provide:
• Practical overview of the current landscape of international AI regulatory guidance
• Latest positions and frameworks from key agencies, highlighting prioritized principles
• Categories of AI addressed
• Nuances across global jurisdictions of AI addressed
Whether your organization is exploring early use cases or scaling AI-driven capabilities, this session will deliver strategic insights and practical guidance. Attendees will gain a foundational understanding of how to navigate AI adoption with confidence, enabling informed decision making and alignment with regulatory expectations.
Speakers:
• Sheila Gwizdak, VP of Consulting
• Jessica Fowler, Associate Principal Consultant
• Caitlin Schuler, Consultant
• Kanchana Iyer, Senior Consultant
