PANEL DISCUSSION: Getting to Grips With Potency Assay Regulatory Guidance & Guidelines
Time: 9:00 am
day: Day One AM
Details:
- Current potency guidance is largely designed to address challenges for biologics, thus what trends or shifts are we likely to observe (which may not be stated in any kind of guidance)
- What is currently driving the trends of potency assay development and regulatory communications?
- Are we any closer to an industry wide standard for potency?
- For potency readouts what’s necessary and what’s sufficient?
- Examining a potential industry knowledge gap in terms of defining function
