AI Theme: AI Perspectives, from Regulators to Regulated

Description

Presentations to include representatives from EMA,  Transperfect, Indegene

Sepanta Fazaeli, Head of AI Solutions, TransPerfect

AI Theme: AI Perspectives, from Regulators to Regulated

Artificial intelligence (AI) is rapidly reshaping how life sciences professionals work, from literature screening and evidence synthesis to pharmacovigilance and clinical evaluation. Yet the regulatory landscape governing AI use has evolved just as quickly. Over the past year alone, the EU AI Act has entered its phased implementation, with AI literacy obligations already applicable since February 2025, the CIOMS Working Group XIV has published comprehensive guidance on AI in pharmacovigilance, the FDA has issued draft guidance on AI for regulatory decision-making, and new standards and guidances continue to emerge from MDCG, ISPE (GAMP), and ISO. For medical writers integrating AI into their daily workflows, keeping pace with these developments, and understanding which ones actually apply, has become a challenge in itself.

This presentation cuts through the complexity by mapping the regulatory landscape into a practical framework. It distinguishes AI deployed as a regulated product (e.g., software qualifying as a medical device) from AI used as a process improvement tool (e.g., title and abstract screening, document drafting), and explains why the same underlying technology can carry fundamentally different regulatory obligations depending on its intended purpose. The session walks through the key requirements that recur across frameworks, explainability, automation bias, human oversight, performance validation, and robustness, and clarifies what each of these terms means in practice.

Tailored for medical writers and regulatory professionals, the talk adopts a risk-based perspective: the regulatory burden associated with AI is not triggered by the label “AI” itself, but by what the AI does, how much it contributes to a decision, and what is at stake if it fails. Attendees will leave with a clearer understanding of where to look when evaluating AI tools, what requirements apply to their specific use cases, and why certain guardrails exist, equipping them to engage with AI adoption confidently and critically in their own work.

Vladimir Penkrat, Associate VP-Head of Regulatory affairs, Indegene

Moderated by Namrata Singh

Followed by a panel discussion of all AI Theme presenters from EMWAs 61st conference, Barcelona.

AI, medical writing, and regulation — separating hype from reality

AI is transforming medical writing—but in regulated environments, speed means nothing without trust. In this panel, industry, AI, and regulatory voices come together to separate hype from reality and unpack what “responsible” AI adoption actually looks like day to day. Expect a practical debate on where AI genuinely saves time, where it adds risk and rework, and what guardrails—from traceability and auditability to human oversight—will define submission‑ready automation. Walk away with clear red lines, realistic opportunities, and concrete next steps medical writers can take in the next 12 months.

AI in regulatory science: moving from principles to practice

Catriona Ester, Scientific Communication Specialist, EMA

Implications for medical writing

Artificial intelligence (AI) offers many opportunities in medicine development and will make an important contribution to helping patients in Europe gain access to innovative medicines. However, as medicine developers and regulators engage with AI, clear guidance on the use of AI-based tools in regulatory science is essential. This presentation will briefly look at some of the ways in which the European Medicines Agency (EMA) is working with AI and promoting best practice for AI use in medicine development. In particular, we will consider how the ten EMA-FDA principles for good AI practice in the medicine lifecycle might apply to medical writing.

Moderated by Lisa Chamberlain James