Panel Discussion: Closing the Gaps in Regulatory Guidance to Improve Biopharma Adherence to Ambiguous Guidelines
Time: 2:15 pm
day: Conference Day Two
Details:
- Navigating pre-submission & cohort design: meeting fda expectations for AI tools
- Where do current regulatory frameworks fall short in addressing AI and digital pathology integration?
- What pre-submission strategies are most effective when engaging regulators on AI-based pathology tools?
- What guidance is needed to support the clinical use of exploratory tools for biomarker and CDx development?
- How can industry work collaboratively with regulators to shape fit-for-purpose standards?
Speakers:
