AI in Regulatory Medical Writing: Balancing Innovation with Human Expertise, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn how AI can support, rather than replace, the essential expertise of medical writing teams. Attendees will gain insight into how AI acts as a powerful co-pilot, enhancing the writer’s productivity, strategic impact and capacity for higher-value work. The featured speakers will discuss how AI will support new, unprecedented timelines and precision we have not yet discovered previously.

TORONTO, Aug. 25, 2025 /PRNewswire/ — The integration of artificial intelligence (AI) is rapidly transforming the landscape of regulatory medical writing, presenting both unprecedented opportunities and critical questions. This webinar will highlight how AI can support, rather than replace, the essential expertise of medical writing teams. The featured speakers will debunk the myth that AI will render human regulatory writers obsolete and instead show how AI acts as a powerful co-pilot, enhancing the writer’s productivity, strategic impact and capacity for higher-value work.

As the landscape evolves, so does the role of the medical writer, shifting from primary content generation to critical oversight, strategic analysis, nuanced interpretation and expert validation. Future-ready writers will be fluent in AI prompting, skilled in validating AI-generated content and adept at solving unstructured, complex problems — uniquely human skills that AI cannot replicate. Writers will need to be trained to guide AI in synthesizing data into narrative, ensuring data integrity and focusing on strategic messaging and effective writing when AI is used to review submissions at agencies like the FDA. This webinar will dive into practical, impactful AI use cases that are revolutionizing workflows and driving unprecedented speed and precision, including for:

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

Finally, this session will explore essential change management strategies to support teams through this transition, fostering psychological safety, designing effective upskilling programs, building governance around AI usage and communicating a clear vision for how AI empowers, rather than diminishes, the vital role of the regulatory medical writer.

Register for this webinar to learn how AI tools translate into significant reductions in time-to-submission, enabling organizations to bring vital therapies to market faster. This session is essential for leaders committed to keeping their regulatory medical writing teams empowered, future-ready and at the forefront of excellence, with skilled human writers consistently at the helm, amplified by AI.

Join experts from the PPD Clinical Research Business of Thermo Fisher Scientific, Maria Hopfgarten, Head of Global Medical Writing; and Sarah Frost, Functional Service Partnership (FSP) Functional Lead for Medical Writing, for this live webinar. Broadcast 1 — North America is on Tuesday, September 9, 2025, at 12pm EDT (5pm BST/UK), and Broadcast 2 — APAC is on Wednesday, September 10, 2025, at 11am UTC+8 (China, Singapore) / 12pm UTC+9 (Japan, Korea).

For more information, or to register for this event, visit AI in Regulatory Medical Writing: Balancing Innovation with Human Expertise (Broadcast 1) or AI in Regulatory Medical Writing: Balancing Innovation with Human Expertise (Broadcast 2).

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit www.xtalks.com
For information about hosting a webinar visit www.xtalks.com/why-host-a-webinar/

Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

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