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Content Governance in the Age of AI: Preparing Pharmaceutical Organisations for ePI and FHIR

About this event

AI-Ready Content Governance for Pharma

A joint webinar from Docuvera and NNIT

ePI/FHIR, IDMP/SPOR, ICH M11, PQ-CMC, and EU ePL are converging on the same operational requirement: structured, machine-readable content as a compliance imperative. The accelerating adoption of AI across the enterprise makes the architecture to support governed content more urgent, not less.

Join regulatory and content governance specialists from Docuvera and NNIT for a practical session on what it takes to make enterprise intelligence regulatory-grade — governed, traceable, structured, and submission-ready at scale.

You will leave with:

  • A clear map of the regulatory mandates and operational timelines forcing action
  • Why interoperability and AI are necessary but not sufficient, and what the governed content layer must do that neither can
  • Practical architecture guidance: data contracts, schema validation, human acceptance gates, and FHIR integration in production
  • Implementation sequencing that reduces validation risk and avoids the failure modes that stall most programmes

Who should attend: Regulatory Affairs, Labelling, CMC, Clinical, Safety, IT, and Digital Transformation leaders (Director through VP) at Top 50 pharmaceutical organisations.

Register above to reserve your spot today, to have your questioned answered live, and to get access to our latest whitepaper.

About Docuvera

Docuvera is the only governance-first structured content platform purpose-built for the pharmaceutical industry. With Docuvera, organizations eliminate manual rework, ensure regulatory-grade quality, and unlock over 80% reuse of content—accelerating submissions and time to market

About NNIT

NNIT is a leading provider of IT solutions to life sciences internationally, and to the public and private sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users and customers.


Hosted by

  • External speaker
    E
    Alexandra Antczak NNIT @ Regulatory Affairs and Clinical Expert

    Alexandra specialises in the transition from document-based to data-centric regulatory operations. With experience across both large pharma and emerging biotech organisations, she advises on regulatory strategy, structured content, and cross-functional data integration.

  • External speaker
    E
    Murali Menon Chief Revenue Officer @ Docuvera

    Murali leads go-to-market strategy, business development, and customer partnerships for life sciences organisations modernising regulated content. With 20+ years in technology and digital transformation, Murali helps pharmaceutical companies transition from document-centric processes to data-driven, component-based workflows that improve governance, compliance, and speed to market.

  • External speaker
    E
    Emilie Troldborg Hansen Regulatory Affairs Consultant @ NNIT

    Emilie specialises in FHIR-based regulatory data systems for global pharma. She works as a business SME helping customers implement pipelines that replace document-centric workflows with structured, interoperable data flows across systems.

Docuvera

Docuvera is the only governance-first structured content platform purpose-built for the pharmaceutical industry. With Docuvera, organizations eliminate manual rework, ensure regulatory-grade quality, and unlock over 80% reuse of content—accelerating submissions and time to market