James Boiani, Member of the Firm, co-presents "Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences" at the Life Sciences AI Summit, hosted by American Conference Institute. The summit runs from February 21 to 22.

Topics include:

  • Understanding the importance of the FDA and EMA in guiding AI’s trajectory in the life sciences
  • FDA’s regulatory framework for AI
    • Examining FDA’s approach to AI-based medical devices and AI algorithms
      • Predetermined Change Control Plans (PCCPs)
    • Reviewing FDA’s guidance on clinical decision support software
    • Understanding how FDA view and categorizes AI-driven medical solutions
  • Appreciating EMA’s position on AI:
    • Exploring EMA’s stance on integrating AI into drug development and patient care
    • Clarifying EMA’s criteria for AI-driven medical applications and their alignment with EU’s AI Act
  • Identifying areas of alignment and disparity between FDA and EMA directives
  • Offering insights on effective strategies for regulatory compliance and proactive engagement with these agencies

For more information, visit AmericanConference.com.

Event Detail

10:15 a.m. - 11:15 a.m.

New York City Bar Association 
New York, NY

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