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TransCelerate Event

Webinar – What’s Next in Accelerating ICH M11 Adoption: Vulcan UDP Implementation Guide

Watch this collaborative webinar to learn about Vulcan’s UDP (Utilizing the Digital Protocol)—a project accelerating ICH M11 and end-user value. You can access previous webinars in the series here.

Slides can be viewed here.

If you are new to Vulcan UDP:

Check out this overview video for a comprehensive background to the Vulcan UDP project and a summary of our progress.

During this webinar, our panelists:

  • Provide a brief overview of the UDP project, including how it complements ICH M11 and TransCelerate/CDISC USDM (Unified Study Definition Model)
  • Highlight the progress towards Vulcan’s publication of an implementation guide (IG), including:
    • Timelines, current status and planned content – what can you expect in the IG
    • Read-out from the May 2025 connectathon and how this supports the IG
    • A look inside the HL7 process and how you can participate  
  • Discuss practical steps to prepare for implementation

Panelists:

  • Hugh Glover, UDP Technical Lead, Vulcan
  • Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis 
  • Stacy Tegan, Program Director, TransCelerate

Ideal Attendees: 

  • Anyone interested in clinical data interoperability
    • Solution providers that utilize clinical protocol information, such as:
      • Study builders and authoring platforms 
      • Structured content management tools 
  • Sponsors and CROs involved in processes that consume protocol information, such as:
    • Protocol and development authoring  
    • Clinical trial digital and technology support 
    • Regulatory operations, submissions & document management 
    • Data managers, innovation managers, infrastructure managers, programmers in clinical development
  • Health Authorities: clinical trial regulators, regulatory submission review (i.e., FDA and EMA)