Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry collaboration through a cloud-based data exchange model. Cesar supports efforts that permit the adoption of the Accumulus platform by both sponsors and regulators. Additionally, he leads a Topic Group Digitalization in Regulatory for IRISS, pushing forward industry-wide digital advancements. Cesar has over two decades of experience, the last 12 years he spent in Submissions Management leadership roles within Regulatory Operations at Pfizer.

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).