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From Prompting to Governance: Working with AI Platforms in Regulatory Medical Writing
Who it is for
Open to EMWA members registered for the EMWA Autumn Conference 2026. Prerequisites will be confirmed with the full workshop description.
What it covers
Artificial intelligence (AI) is transforming regulatory medical writing from a content-generation tool into a catalyst for structured, AI-enabled workflows. As AI platforms become more sophisticated, medical writers are taking on expanded responsibilities in selecting appropriate technologies, designing effective workflows, and ensuring quality, compliance, and accountability. This interactive 90-minute session provides a practical framework for integrating AI into regulatory writing, covering platform selection, prompting, context management, and output validation. Through real-world examples and quality control strategies, participants will learn how to identify AI limitations, mitigate risks such as hallucinations and data inconsistencies, and strengthen their role as process owners and quality gatekeepers in the responsible adoption of AI.
Session Objectives
At the end of this session, you will be able to:
· Identify key criteria for selecting AI-enabled medical writing platforms for enterprise organizations, small agencies, and freelance practices.
· Describe the core components of effective AI engineering for regulatory writing: prompting, context, and harnessing.
· Evaluate the strengths, limitations, and variability of AI-generated content across different tools and platforms.
· Apply a practical quality control framework to identify hallucinations, data inconsistencies, and loss of clinical nuance in AI-generated outputs.
· Define the ongoing responsibilities of medical writers as process owners, scientific interpreters, and quality gatekeepers in AI-enabled workflows.
Sharon Kim, PharmD, is the founder and CEO of MPilot, an AI company developing solutions for clinical trial design and regulatory documentation. A regulatory medical writer with experience at Pfizer, Genentech, and Gilead, she has spent more than a decade navigating the scientific, regulatory, and operational complexities of drug development. She is passionate about helping organizations integrate AI into high-stakes workflows responsibly. Her work centers on aligning AI innovation with regulatory rigor, human
Mati Kargren currently serves as a Medical Writing Optimization Lead, GSK, where he drives strategic initiatives to enhance regulatory document development processes and technological integration. Prior to this role, Mati held the position of Medical Writing Services Technology Consultant at Parexel International, where he spearheaded the implementation of a department-wide structured content management (SCM) platform and led the integration of generative AI capabilities to optimize clinical study content creation workflows.
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Registration fee first
The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
Invoices must be settled by bank transfer in Euro, or paid by card through Stripe. All fees are payable in advance. Full payment is due by 30 October 2026. If payment has not been received, EMWA reserves the right to request payment and cancel registration.