Advancing Analytical Development Strategy for Successful IND/IMPD Applications Through All Stages of Product Development
Time: 12:15 pm
day: Conference Day Two
Details:
- Discuss the importance of strategic assay development tailored to the specific characteristics of cell therapy products, emphasising the need for comprehensive characterisation assays and how to use these assays during product development
- Explore strategies for aligning with regulatory expectations and interpreting guidance documents effectively.
- Discuss why and when to proactively engage with regulatory agencies during product development
- Highlight the value of collaborative risk assessment and mitigation efforts involving cross-functional teams and how those activities guide the control strategy for the product and analytical development.
- Analytical development approaches in ICH Q14 will be discussed
