Tackling Key Considerations of Platform Assays & Methods According to Recent Guidance
Time: 9:50 am
day: Day One
Details:
- Understand how platform assays ensure standardised methods for reliable and reproducible results across various formulations and batches
- Learn how minor formulation tweaks may stay within the same platform, but significant changes could require validation and regulatory re-submission
- Discuss how modifications to critical quality attributes or biological outcomes often trigger the need for new validation and full regulatory submission
