Summary:
The RAPS Global Regulatory Strategy Conference discussed AI’s role in regulatory science, highlighting challenges in harmonization, data privacy, and evolving regulations. Collaboration among regulators and industry is essential for effective oversight.
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Reporting LIVE from the RAPS Global Regulatory Strategy Conference: “AI in Regulatory Science: Past, Present, and Future” AI is here to stay—but is regulatory science ready for it? The opening plenary at the RAPS Global Regulatory Strategy Conference explored the evolving role of AI in regulatory decision-making, from medical device approvals to pharmaceutical development. With over 950 AI-driven medical devices cleared by the FDA, AI’s regulatory footprint is growing, but questions remain about harmonization, data privacy, and the regulatory frameworks needed to keep up. “The more things change, the more they stay the same,” said Antonella Lozito-Heerschap, Pharm.D. (Moderna), who moderated the session. While AI promises to speed up processes and improve decision-making, the fundamental challenges of data quality, transparency, and risk management remain. Key Challenges & Considerations 🔹 Global Harmonization is Still a Work in Progress. AI-driven products don’t operate in one regulatory bubble—they must comply with FDA, EMA, and other agency requirements. Leon Doorn (MedQAIR) expressed concerns that inconsistent global regulations could slow AI adoption, creating barriers to innovation rather than enabling it. 🔹 Data Privacy and Cybersecurity Risks are Growing. With AI models pulling in massive datasets across multiple sources, the risks related to data integrity, patient privacy, and cybersecurity are increasing. Ridwana Isla, PMP (Boehringer Ingelheim) highlighted the urgent need for clearer guidance on AI-driven data handling and security measures to prevent regulatory and ethical missteps. 🔹 AI-Specific Regulations Are Inevitable. Current regulatory frameworks weren’t built for AI, and the industry is already seeing new requirements emerge. Camille Vidal (GE Healthcare) noted that AI introduces an entirely new set of compliance obligations that regulators will need to “beef up” over time—particularly in areas like post-market monitoring and performance validation. Takeaways: What’s Next? ✅ AI isn’t replacing regulatory expertise—it’s reshaping it. Regulators and industry leaders must collaborate on clearer frameworks for AI validation and oversight. ✅ The biggest regulatory hurdle isn’t AI itself—it’s uncertainty. Companies need proactive strategies for managing evolving AI regulations across different markets. ✅ Expect stricter post-market monitoring. AI-enabled products may require continuous validation, real-world performance tracking, and transparency in decision-making to maintain compliance. The session made one thing clear: AI is moving fast, but regulation is still playing catch-up. How companies navigate this shifting landscape will define their success in AI-driven innovation. Looking forward to more discussions throughout the conference. Thoughts? Drop them below.👇 #RegulatoryAI #MedTech #Pharma #RAPS2025