Jun 15, 2026 · 2:30 PM – 3:30 PM ET · 204AB

The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, MHRA, and PMDA

Senior leaders from FDA, EMA, MHRA and PMDA share insights on AI's evolving role in regulatory review & decision-making. Attendees will explore current practices, key challenges, and future opportunities for AI in shaping global regulatory frameworks.

Also: 其他演讲人：Jingyu (Julia) Luan (AstraZeneca)

Jun 15, 2026 · 2:30 PM – 3:30 PM ET · 109AB

ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science

Explore how ICH M11, AI, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design, streamline submissions, and foster patient-centered innovation.

Also: 其他演讲人：Vada Perkins (Boehringer Ingelheim) · Robert DiCicco (TransCelerate Biopharma Inc.) · Jimita Parekh (DNAnexus)

Jun 16, 2026 · 4:15 PM – 5:15 PM ET · 105AB

Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate

This session explores how lean authoring streamlines clinical regulatory documents, debunks myths about reviewer preferences, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.

Also: 其他演讲人：Lauren Geary (Eli Lilly and Company) · Inger Nielsen (Novo Nordisk A/S)

Jun 17, 2026 · 4:00 PM – 5:00 PM ET · 117

Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases

This session explores AI's role in pharma, offers regulators' insights and Q&A, introduces a Gen AI validation framework, and showcases use cases in audit report authoring and process/knowledge management chatbot, highlighting ethical, time/cost efficient, and compliant AI adoption.

Also: 其他演讲人：Oliver Fink (Boehringer Ingelheim) · Haleh Valian (Biogen) · Srilatha Endabetla (Bristol Myers Squibb)

Jun 16, 2026 · 4:15 PM – 5:15 PM ET · 109AB

Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU

This session examines evolving US and EU regulatory approaches to AI in drug development and explores how policy expectations are translated into real-world GxP implementation. Attendees will gain insight into regulatory convergence, operational challenges, and good practices for compliant AI adoption.

Also: 其他演讲人：Junyang Wang (EMD Serono) · Martin Heitmann (ISPE)

Jun 16, 2026 · 10:15 AM – 11:30 AM ET · 105AB

Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development

This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency-level initiatives.

Jun 17, 2026 · 10:15 AM – 11:30 AM ET · 109AB

Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech

Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models, examines FDA, EMA, and EU AI frameworks, and delivers strategies to ensure credible, compliant AI use in regulatory decision-making.

Also: 其他演讲人：Mark Rutter (Formation Bio) · Donna Rivera (Canal Row Advisors) · Graziella Collu (AstraZeneca)

Jun 17, 2026 · 10:15 AM – 11:30 AM ET · 115AB

Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies

This session will explore how regulators are preparing to implement the New EU Pharmaceutical Legislation, turning the digital-by-default ambition into practice, combining legislative reforms with digital and AI strategies.

Also: 其他演讲人：Jeppe G. Manuel (Novo Nordisk A/S)