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TransCelerate Event

Webinar: Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value 

Join us to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project that brings together multiple initiatives to develop a digital representation of a study protocol.

During this webinar, our panelists will:

  • Outline the goals of the UDP project, addressing the who, what, when, where, and why aspects.
  • Deliver a summary of the first UDP Connectathon in May, highlighting the feedback, key learnings, and planned follow-up actions.
  • Describe the intent and potential impact of M11 from the ICH M11 perspective.
  • Announce the upcoming UDP Connectathon in September, detailing its goals and objectives, providing information on where to find more details, and explaining how to participate.
  • Facilitate a Q&A at the end of the webinar.

Panelists:

  • Hugh Glover, Technical Director, Vulcan
  • Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis
  • John Owen, Head of Project Management, CDISC
  • ICH M11/EMA speaker to be named*
  • ICH M11/FDA speaker to be named*

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 Manager; Innovation Manager, Infrastructure Manager, 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.