FDA & EMA Jan 2026 AI Statement: Regulatory Principles vs. Lab Reality (Episode 2) скачать в хорошем качестве

FDA & EMA Jan 2026 AI Statement: Regulatory Principles vs. Lab Reality (Episode 2)

https://despharmaconsulting.com/ In this episode of the DES Pharma Podcast, we unpack the January 14, 2026, joint announcement from the FDA and EMA regarding "Good AI Practice." We discuss the hierarchy of AI tools currently hitting the market: 1) Foundational Models: General purpose bots like Gemini and Claude. 2) Wrappers: Apps built on top of models (e.g., Benchling AI, Viva Suite). 3) Hybrid/Sophisticated Models: Mechanistic models combined with Machine Learning for high-level control. We also dive deep into the "Infrastructure Gap." While the regulations call for ethics and safety, the reality on the manufacturing floor is different. We discuss the necessity of the FAIR data principles (Findable, Accessible, Interoperable, Reusable) and why legacy equipment and messy Excel sheets are currently preventing the industry from realizing the dream of "self-driving labs." Finally, we explore how AI can assist in Design of Experiments (DoE) to reduce trial and error in Analytical Development, provided the validation and data integrity hurdles can be overcome. Timestamps: 0:00 - The Jan 14, 2026 FDA/EMA Announcement 6:50 - 3 Pillars of AI: Models, Wrappers, & Hybrids 11:00 - The FAIR Data Principles & Intelligent Automation 15:00 - AI in Analytical Method Development 22:00 - Data Silos & Validation Barriers