AI in Regulatory Medical Writing: Balancing Innovation with Human Expertise (Broadcast 1)

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.

Speakers

Maria Hopfgarten, Head of Global Medical Writing, PPD Clinical Research Business of Thermo Fisher Scientific

Maria Hopfgarten brings over 20 years of experience leading global, high-performing teams, implementing technology improvements and increasing revenue and profitability via expanded business services. Maria currently serves as the Head of Global Medical Writing for the PPD clinical research business, leading a global team that focuses on regulatory, clinical and patient-facing materials. Previously, Maria established the Language Services Department for the Clinical Development Services Division. Throughout Maria’s career, she has implemented AI for language and medical writing efficiencies and overall process improvements, reducing timelines and cost.

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Sarah Frost, Functional Service Partnership (FSP) Functional Lead for Medical Writing, PPD Clinical Research Business of Thermo Fisher Scientific

Sarah Frost, PhD, is a distinguished medical writing professional with 19 years of experience in the clinical research and pharmaceutical industry. As the Functional Lead for Medical Writing FSP at Thermo Fisher Scientific, she spearheads the management and operations of a global team, driving excellence in the delivery of FSP solutions with an unwavering commitment to customer satisfaction. Sarah holds a PhD in Molecular Biology from the University of Keele and has held various leadership roles, including Senior Director at Thermo Fisher Scientific. She is recognized for her strategic vision, leadership and dedication to fostering high-performance cultures, coupled with her expertise in process improvement. She excels in supporting teams through change management, including leveraging AI to enhance efficiencies and drive innovation.

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