Please join us on Wednesday, 13 May 2026 for a DIA MW Community Shared Learning Session led by a panel of four seasoned regulatory medical writers (link to be provded) The session will review the current state of AI and its role in regulatory document development, including an assessment of the strengths and limitations of AI-generated regulatory content. Through a hands-on practicum examining AI-generated CSR sections, panelists will evaluate output quality and discuss appropriate next steps. The session will conclude with a panel discussion and audience Q&A focused on practical considerations for the use of AI in regulatory writing. Panelists include Abe Shevack Namrata Singh, Nancy Katz, and Sharon Kim.*
Session Learning Objectives: At the end of this one-hour session you will be able to:
· Describe the security and system requirements necessary for a useful AI tool
· Describe the ethical responsibilities of the MW who uses an AI tool
· Evaluate the strengths and limitations of AI-generated material for regulatory documents (e.g., CSRs, study protocols, etc)
· Determine the next steps of the MW when given AI-generated content for a regulatory document
* Panelists
Abe Shevack MA, ELS has over 20 years as a senior scientific medical writer, contributing to successful drug authorizations across multiple therapeutic areas and working since 2016 as a freelance consultant for Pharma and Biotech clients. He is Past President of the European Medical Writers Association (EMWA), a workshop leader, and Chair of the EMWA Ambassador Programme.
Namrata Singh, MBBS, DNB (Paediatrics), MBA is the founder and CEO at Turacoz Group which provides strategic solutions to biopharma companies, medical technology firms, healthcare professionals, and research institutes around medical writing, evidence generation, insights gathering and medical education. She is an active member of societies like European Medical Writers Association (EMWA), American Medical Writers Association (AMWA) and International Society of Medical Publication Professionals (ISMPP). She is the chair of AI working group and Entrepreneurship Special Interest Group at EMWA. She participates as speaker, organizing member and has authored publications around medical writing.
Nancy R. Katz, PhD, MWC is President of Illyria Consulting Group, Inc. which specializes in the development of eCTD-compliant documents for the biopharmaceutical and medical device industries. An active member of AMWA and DIA and AI advocate, she is a past president of AMWA’s Northern California chapter, currently chairs its Governance Committee, and serves as Education Coordinator for the DIA Medical Writing Community.
Sharon Kim, PharmD, is the founder and CEO of MPilotAI, an agentic AI platform that supports clinical research teams by analyzing evidence, structuring trial design decisions, and generating aligned regulatory documents. A medical writer with experience at Pfizer, Genentech, and Gilead Sciences, she has spent over a decade navigating the regulatory, ethical, and operational complexities of drug development. She focuses on bridging AI innovation with regulatory rigor to help teams produce high-quality, compliant documents at scale. She studied at Cornell University and earned her PharmD from the University of Washington and serves as AMWA AI Education Subcommittee Coordinator.
Linke to be provided.