Enhancing Potency Assay Strategy for CGT: Unlocking Precision & Reliability for Regulatory Approval
Time: 10:00 am
day: Conference Day One
Details:
- Delve into the new potency assurance guidance and understand how to align potency methods with regulatory requirements to meet expectations and ensure compliance. Explore effective strategies to mitigate risks to a product’s potency
- Discover how collaborative initiatives streamline compliance efforts and facilitate the adoption of best practices, particularly in addressing the complexities of new regulatory guidance and ensuring alignment with evolving expectations
- Learn effective strategies for engaging with regulators early and continuously throughout the cell therapy development process
