Cesar Vinces is Founder and Principal Advisor at Nuvara, where he advises industry organizations on the evolution of next-generation regulatory operating models, digital transformation, regulatory innovation, AI-enabled regulatory capabilities, and emerging technologies. He has more than 20 years of experience in global regulatory operations, leading global dossier delivery, enterprise transformation, regulatory innovation, and international regulatory collaboration. His current work focuses on the future of regulatory operations and the practical integration of AI and emerging technologies across the regulatory ecosystem.

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Ed Hammond has provided vision and leadership in most aspects of health informatics for over sixty years. He has been engaged in AMIA, ACMI, IMIA, HL7 International, ISO TC 215, JIC, IEEE, ACM, PAHO, IADB, and various US Government agencies over the years. His current research is in data visualization; realizing interoperability using HL7 FHIR®, SMART®, and CDS Hooks; wearable sensors; app development; domain analysis modeling, registries, EHRs, databases, human metrics, SDOH, and creating a master set of common data elements. He is leading an effort, Galileo, to define a perfect health system by conducting "think-aloud" session with multiple groups of persons. He is Captain USNR (ret).