Part II: Navigating FDA and EMA Directives: Shaping AI’s Role in the Life Sciences
James Boiani
Shareholder
Epstein Becker & Green, P.C.
Philip Desjardins
Partner
Arnold & Porter
(Former Associate Director for Policy, FDA Center for Devices and Radiological Health)
Donielle Johnson
Former VP Global Regulatory Affairs
Bausch + Lomb
Hannah Rosenfeld
Digital Health Specialist
FDA
- 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