The State of Global Regulatory Compliance 2026:

Digital submissions, UDI expansion, and evolving regulatory expectations

Regulatory frameworks worldwide are entering a new phase defined by structured data, centralized device databases, and machine-to-machine submission models. As global authorities expand UDI requirements and modernize submission infrastructure, life sciences organizations face increasing pressure to strengthen data governance, while navigating evolving regulatory expectations and increasing data oversight.

This forward-looking webinar brings together regulatory and digital compliance experts to examine two converging forces shaping global compliance strategy in 2026:

1. Global UDI and database expansion
   Australia's UDI expansion and SPL-enabled machine-to-machine submissions are accelerating structured data adoption, while Switzerland's Swissdamed voluntary registration phase offers manufacturers an early opportunity to validate processes ahead of mandatory requirements. We will also review EUDAMED implementation progress and evolving readiness expectations under the EU MDR and IVDR.
2. The shift to FHIR-based regulatory data exchange
   FHIR is moving from concept to operational reality. We will explore how regulators are adopting HL7^® FHIR^® standards to enable interoperability, improve data quality, and modernize submissions — and what this means for regulatory IT strategy, master data management, and scalable global compliance infrastructure.

Attendees will gain practical insight into how these developments intersect — and how organizations can align regulatory and IT functions to proactively manage risk while preparing for the next generation of digital regulatory compliance.

Panelists

John Lorenc is the Director of Product Management at LexisNexis Life Sciences Solutions, specializing in delivering innovative solutions that address complex regulatory product data submission requirements for the Life Sciences industry, including both pharmaceuticals and medical devices. With a strategic focus on compliance, efficiency, and customer success, John leads the development and optimization of products that empower organizations to meet evolving global regulatory standards with confidence. Drawing on deep industry expertise and a passion for solving critical data challenges, John partners closely with regulatory, technical, and business stakeholders to ensure solutions not only meet compliance demands but also drive operational excellence.

Ami Mehr is a patient-focused executive leader with a career dedicated to accelerating the delivery of life-changing therapies, grounded in the belief that every day of waiting matters.

She is the former Chief Operating Officer at Evinova, a digital health company incubated within AstraZeneca, with responsibility for global operations spanning quality, compliance, commercial delivery, and business continuity across an AI-enabled portfolio supporting clinical trials and real-world evidence.

She has facilitated countless executive and cross-functional sessions, creating alignment, clarity, and momentum in complex environments. Her experience spans the full R&D lifecycle, working with startups and established pharma, biotech, and medtech organizations.

Sam Thompson is an Independent Consultant who leverages his extensive background in pharmaceutical data architecture to deliver tailored solutions aligned to each client's regulatory, compliance, and operational needs. He specializes in designing and implementing data strategies that ensure compliance, scalability, and operational efficiency in pharmaceutical organizations.

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