The FDA Group’s Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.
Maria draws on two decades of leadership across nonprofit, government-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA’s global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and technology developers to advance responsible, evidence-driven innovation.
In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what’s currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA’s convening role.
Key topics discussed include:
How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrieval
Why validation must focus on end-to-end workflow integrity, not just the model
The emerging role of risk-based tiers for AI-enabled tools
The importance of lifecycle control frameworks such as TPLC and PCCPs
Global convergence themes around transparency, bias mitigation, and human accountability
How agencies are preparing for increasing AI adoption—and what industry teams should be doing now
DIA’s role as a neutral convener helping harmonize expectations and accelerate responsible innovation
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