Highlights & Features

What is happening at Regulatory Submissions, Information, and Data Management Forum

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Track Alignment for 2027!

Track 1: Establishing Robust Foundations for a Sustainable Regulatory Ecosystem

How do I build the capability?

This track focuses on the practical establishment and execution of core RSIDM capabilities across process, data, and technology. It examines how organizations define and implement foundational processes spanning document authoring, structured data management, regulatory submissions, and compliance outputs while adhering to the latest technical guidelines and data standards.

Track 2: Optimizing Processes and Procedures

How do I make the capability perform better?

This track is designed for regulatory professionals focused on improving day-to-day execution of regulatory submissions and data processes in a complex, global environment. The typical attendee is a regulatory leader (Examples: senior manager, director, or global process owner) working in mid-to-large pharmaceutical, biotech, or regulatory service organizations, where they are responsible for delivering submissions, improving process efficiency, and scaling operations across regions and systems.

Track 3: AI, Automation and Emerging Technologies

What technologies can help me?

This track explores how organizations can translate AI, automation, and emerging technologies into practical, trusted, and scalable capabilities. Sessions move beyond the promise of innovation to examine where technologies are delivering value today, where implementation remains challenging, and how organizations are addressing validation, compliance, integration, human oversight, and platform/tool selection. Attendees will gain practical insights from real-world deployments, failed or stalled pilots, and novel digital approaches, including how organizations are balancing existing enterprise platforms and new technologies. This focus area will help attendees assess what technologies are fit for purpose, establish the controls needed for sustainable operations, and accelerate modernization across submissions, information exchange, and technology-enabled workflows.

Track 4: Strategic Leadership and Organizational Readiness

How do I transform the organization?

This track explores the organizational, leadership, and strategic forces that drive successful regulatory transformation and prepare companies for the rapidly evolving global landscape. The track examines how forward thinking planning, agile governance, and enterprise aligned regulatory strategy enable organizations to build truly future ready regulatory capabilities.

Sessions will move beyond foundational execution and technology optimization to address the broader structural enablers of regulatory excellence. Key themes include defining and building next generation regulatory organizations; transforming operating models across centralized and decentralized structures; strengthening global and regional governance; and addressing capability gaps through talent development and workforce transformation.

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Regulatory Submissions, Information, and Data Management Forum