Enhancing Regulatory Strategies & Navigating Eyebrow Raising Regulatory Guidelines for Streamlined Compliance
Time: 9:30 am
day: Conference Day One
Details:
- Learn effective strategies for engaging with regulators early and continuously throughout the cell therapy development process. Understand how to navigate evolving regulatory landscapes, including recent guidelines such as Q14 on analytical development and Q2 R2 on method validation. Gain insights into implementing these guidelines effectively and addressing any controversial aspects or recommended modifications raised by regulatory bodies.
- Explore the latest methodologies used to characterize cell therapies, considering regulatory expectations outlined in recent potency draft guidance. Delve into the nuances of assay validation for potency assessment and understand how to align analytical methods with regulatory requirements to meet expectations and ensure compliance.
- Discover the benefits of industry collaboration in establishing standardized approaches to analytical development, including interpretation and implementation of regulatory guidelines. Explore 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.
