Navigating Regulatory Waters: Insights into Cell Therapy Analytical Development Across the Regulatory Landscapes
Time: 2:15 pm
day: Conference Day Two
Details:
- Explore the efforts to harmonise regulatory standards for cell therapy analytical development across the US, EU, and UK.
- Discuss the importance of aligning regulations to ensure consistency in product quality and safety assessments
- Delve into the unique regulatory challenges and considerations faced by cell therapy developers.
- The differences in regulatory pathways, requirements, and expectations, and how they impact analytical development strategies
- Examine strategies for adapting to evolving regulatory landscapes.
- Discuss the importance of staying abreast of regulatory updates, engaging with regulatory agencies, and proactively addressing emerging requirements to ensure compliance and expedite product development
