Artificial intelligence is transforming drug discovery, clinical development, and commercialization, often at an unprecedented pace. Governments and regulatory agencies in the US, EU, and China are rapidly developing frameworks that balance innovation with patient safety, data governance, and ethical principles.

This session will explore how the rapidly evolving and fragmented regulatory landscape around AI in pharma and biotech impacts IP, privacy, and compliance.
It will focus on how these intersecting regimes create both legal risk and potential litigation exposure.
The discussion then shifts to how companies can move from regulatory complexity to practical, cross-jurisdictional compliance strategies.

Topics of discussion include:

• Interpreting recent AI regulatory frameworks in the US, EU, and China: where AI regulation stands today in key markets, what high-level updates have emerged over the past year, and what new laws and policies are on the horizon.
• Multiregional collaboration and its practical implications.
  • E.g., the EMA and FDA’s joint AI guidance for medicine development (January 2026), as well as ASEAN’s Guidance on AI Governance and Ethics.
• Navigating AI transparency, trade secrets, and patent protection.
• Understanding privacy fundamentals in AI: Navigating global regulatory diversity.
• Evaluating key ethical and governance considerations, including bias mitigation, transparency, explainability, and patient safety in AI-driven processes.
• Comparing global approaches to the cross-regulatory landscape, highlighting similarities, divergences, and lessons for multinational strategy.
• Bridging regulatory divergence: Global strategies across AI, IP, and Privacy.