AI as Co-Pilot in Regulatory Medical Writing: Empowering Human Expertise for Faster, More Precise Submissions

AI in Regulatory Medical Writing: Balancing Innovation with Human Expertise

Medical writing teams face new challenges and opportunities as artificial intelligence (AI) becomes part of their workflow. This free webinar hosted by Xtalks will explore how AI can support—and not replace—the expertise that writers bring to regulatory medical documents.

Attendees will learn how AI acts as a co-pilot, boosting productivity and allowing writers to focus on higher-value tasks that require strategic insight and nuanced judgment. The discussion will include how AI helps meet tighter deadlines and deliver a level of precision previously unseen in the field.

What You’ll Learn

AI is changing the role of medical writers. Instead of solely creating content, writers are increasingly responsible for overseeing AI-generated drafts, interpreting complex data, and validating the accuracy of submissions. This webinar will address how writers can develop skills in AI prompting and content validation to remain essential contributors in regulatory processes.

Key human skills—critical thinking, expert judgment, and strategic messaging—remain irreplaceable by AI. Writers will learn how to guide AI in synthesizing data into clear narratives while ensuring data integrity and compliance, especially when submitting to agencies like the FDA.

Practical Applications of AI

The webinar will cover real examples of AI improving workflows and accelerating timelines for documents such as:

• Informed consent forms
• Clinical study reports
• Lay summaries
• Review and quality control across all regulatory medical writing

Additionally, it will address how to manage the human side of this transition—building psychological safety, creating upskilling programs, establishing governance for AI use, and communicating a clear vision for AI’s supportive role.

Who Should Attend

This session is essential for regulatory medical writing leaders and team members aiming to stay ahead in their field. Learn how AI tools can meaningfully reduce time-to-submission so that critical therapies reach patients faster—all while keeping skilled human writers in control.

Event Details

Join Maria Hopfgarten, Head of Global Medical Writing, and Sarah Frost, Functional Service Partnership (FSP) Functional Lead for Medical Writing, both from the PPD Clinical Research Business of Thermo Fisher Scientific, for this live webinar.

• Broadcast 1 — North America: Tuesday, September 9, 2025, at 12pm EDT (5pm BST / UK)
• Broadcast 2 — APAC: Wednesday, September 10, 2025, at 11am UTC+8 (China, Singapore) / 12pm UTC+9 (Japan, Korea)

For more information and to register, visit the webinar pages for Broadcast 1 and Broadcast 2.