
AI in Regulatory Medical Writing: Balancing Innovation with Human Expertise
Artificial intelligence (AI) is reshaping regulatory medical writing by augmenting expert teams, not replacing them. Medical writers’ roles are shifting with the landscape; moving from content generators to strategists. Practical skills like effective prompting, validating outputs, turning data into narrative, safeguarding data integrity, and writing strategically as agencies (e.g., the FDA) adopt AI in review are needed for the future of medical writing.
In this webinar you’ll discover:
- Practical AI use cases to enhance workflows, speed and precision in medical writing.
- Specific applications that include informed consent forms, clinical study reports, lay summaries and quality control.
- How to communicate a clear vision on how AI empowers regulatory medical writers rather than diminishing their roles.
- How AI acts as a co-pilot, elevating writers’ productivity and strategic impact and translating into significant reductions in time-to-submission, enabling organizations to bring vital therapies to market faster.
Speakers:

Maria Hopfgarten
Head of Global Medical Writing, PPD clinical research business of Thermo Fisher Scientific

Sarah Frost
Senior Operations Strategy Lead, PPD clinical research business of Thermo Fisher Scientific