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Beyond eCTD and eStar: how quality drives true digital transformation in life sciences

See how quality teams can lead meaningful, future-ready digitalization.

Agenda

08:50
Why digital transformation matters

11:10
The context today: beyond eCTD & eSTAR

19:55
Quality as a key enabler and beneficiary

25:35
Challenges and risks with new technologies

33:36
The rumble in the digital QA/RA jungle

46:30
Q&A

Digital transformation in life sciences is accelerating, and while attention often goes to electronic submissions, regulators are increasingly using digital and AI-assisted tools to assess quality and data integrity with far greater speed. Many companies still rely on “paper-thinking,” digitizing old processes instead of preparing for machine-assisted review, where even small inconsistencies can trigger scrutiny. In this session, Martin King, Regulatory Affairs and Quality Assurance expert, and Angel Buendía, Scilife’s Knowledge Manager, will show how quality teams can lead by strengthening transparency, rigor, and data integrity as regulators move toward AI-assisted audits and structured, machine-readable submissions.

You’ll learn how to:

  • Grasp digital transformation beyond basic electronic formats.

  • See how quality teams drive and benefit from digitalization.

  • Understand new risks and validation needs from emerging tech.

  • Prepare for evolving, AI-enabled regulatory expectations.