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What's Next in Accelerating ICH M11 Adoption: Vulcan UDP Implementation Guide 

 

Event Date: Wednesday, 25 June 2025

Event Time: 9:00 to 10:15 a.m. EST

 

Building on the success of our previous webinars, we're excited to announce the next webinar in the series! Join us as we explore Vulcan’s UDP (Utilizing the Digital Protocol)—a project accelerating ICH M11 and end-user value. 

 

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 will:

  • 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)
     

TransCelerate webinars may be recorded in whole or in part.