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
- Examining FDA’s approach to AI-based medical devices and AI algorithms
- 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
