The AI Compliance Playbook: Navigating EMA and FDA Draft Guidances скачать в хорошем качестве

The AI Compliance Playbook: Navigating EMA and FDA Draft Guidances

As artificial intelligence becomes increasingly embedded in clinical research, regulators are stepping up with frameworks to ensure its safe and effective use. This panel builds on earlier discussions and dives into the recent draft guidances and position papers from the FDA and EMA, which outline expectations for AI tools used in clinical trials from risk-based credibility assessments to lifecycle governance and transparency. Panelists explore practical controls organizations can implement to align with these evolving standards, and how the principles in these guidances can be applied to real-world clinical trial operations. Whether you're deploying AI for data analysis, patient recruitment, or protocol compliance, this session will help you navigate the regulatory landscape with confidence. 00:00 – Welcome & Panel Introductions 04:58 – Setting the Regulatory Context for AI in Clinical Trials 05:01 – Question 1: How Should AI Be Validated in GxP Environments? 10:29 – Reproducibility, Deterministic vs Probabilistic AI 18:03 – Ethics, Risk-Based Approaches & Patient Impact 22:43 – Governance, AI Hype & When Not to Use AI 24:04 – Industry Frameworks: GAMP, ISPE & Practical Guidance 26:36 – Question 2: Transparency & Explainable AI 30:13 – Question 3: Ongoing Compliance & Model Monitoring 36:01 – Audience Q&A, Key Takeaways & Session Wrap-Up