Navigating Regulatory Challenges for Cell and Gene Products in 2024 and Beyond

Please join us for an exploration into the complex regulatory landscape of cell and gene therapies. In this webinar, you will learn from the Cardinal Health Regulatory Sciences team as they share insights based on recent FDA guidance and provide important considerations for cell and gene therapy (CGT) development.

This multi-discipline panel of experts will discuss a variety of essential topics, including:

• The importance of ancillary and starting materials management control strategies for CGT product development
• Recent FDA regulatory developments for expedited regulatory pathways for cell and gene therapy products, specifically the recent regulatory initiatives for improving efficiency of accelerated approval pathway
• Regulatory considerations crucial for using companion diagnostics in cell or gene therapy