Event
RAPS US Convergence
October 7 - October 9, 2025
Pittsburgh, Penn.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS Institute is an affiliated organization that is home to the Regulatory Affairs Certifications (RAC) and the Regulatory Compliance Certifications (RCC), the only post-academic professional designations to recognize regulatory excellence in the healthcare products sector.
The event features the regulatory community gathers to discuss the topics you want to learn, with expert speakers offering practical insights you can apply right away. Designed with Community in Mind. Making real connections with industry professionals, health authority personnel, and more. Participate in interactive educational forums designed to spark conversation. Discover the latest industry innovations.
The event expects 2,000 attendees representing medical devices, pharmaceuticals, bio and biotech.
Visit our booth, 606 and learn from our industry experts!
Tala H. Fakhouri, Ph.D., M.P.H.
Vice President Consulting, AI & Digital Policy, Real-World Research
Wednesday, October 8, 12:30 – 12:55p.m.
Spark Theatre 637
Title: Speed without shortcuts: Navigating regulatory boundaries for AI applications in clinical trials
Drawing on our speakers’ experience from FDA and the practical implementation of AI solutions in regulatory workflows, we level set on the difference between tools that enhance operational efficiency and those that require regulatory consideration and agency input. We discuss practical approaches to de-risk AI implementation while maintaining compliance with regulatory expectations. We focus on how to deliver measurable benefits through responsible AI adoption, illustrated through a real-world IND application case study.
Ryan Zettle
Head of Regulatory Submissions, Americas, Regulatory Consulting
Wednesday, October 8, 12:30 – 12:55p.m.
Spark Theatre 637
Title: Speed without shortcuts: Navigating regulatory boundaries for AI applications in clinical trials
Drawing on our speakers’ experience from FDA and the practical implementation of AI solutions in regulatory workflows, we level set on the difference between tools that enhance operational efficiency and those that require regulatory consideration and agency input. We discuss practical approaches to de-risk AI implementation while maintaining compliance with regulatory expectations. We focus on how to deliver measurable benefits through responsible AI adoption, illustrated through a real-world IND application case study.
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