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Evaluation ViewAttendees 5

Pre-Conference Workshop

Digital Health

Pharmaceuticals

Medical Devices

Pre-Conference Workshop: Driving Change: How to Successfully Implement AI and Digital Transformation in Regulatory Affairs (MD, Pharma, IVDR)

Tuesday, May 5, 2026
08:30 - 16:00 WEST
Location: Pavilion 5 - Room 5C
Learning Level: Advanced
Click here to download the agenda

Description: This pre-conference workshop builds on the highly interactive session from the last RAPS Euro Convergence and takes the discussion to the next level. While many organizations are exploring digital and AI-supported tools for regulatory and quality management, the real challenge lies not in technology itself but in mindset, change management, and organizational culture.

Participants will be guided through the journey of digital transformation in regulatory affairs, using insights from a recently published industry whitepaper. The workshop will address how to create urgency for change, build a guiding coalition, and engage colleagues across functions to enable successful adoption. Interactive sessions will highlight the barriers and enablers of digital transformation, with practical examples of how to move from pilot projects to sustainable implementation.

In cross-pollination workshops, special attention will be given to how digitalization and AI tools can support regulatory processes across pharma and medtech – and what it takes to embed these tools in daily operations. The workshop will feature perspectives from industry, associations, authorities, notified bodies and consulting, offering a holistic view on what really drives success when implementing digital and AI projects in organizations.

Participants will leave with a structured framework and actionable strategies to initiate and manage transformation projects in their own organizations.

Learning Objectives:

  • Identify key organizational and cultural factors that determine the success of digital and AI adoption.
  • Apply change management principles to initiate and sustain digital transformation in regulatory affairs.
  • Recognize enablers and barriers when implementing AI-supported tools in regulatory and quality processes.