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UDP Webinar 2

Time: 9:00-10:30 Eastern 15:00-16:30 CEST

Vulcan UDP: Collaborating to Accelerate ICH M11 and End User Value

Agenda:

  • Ron Fitzmartin from the FDA and Noemie Manent from the EMA talked about the development of the M11 Template for a protocol and the impact this will have.

  • Chris Decker from CDISC talked about the development of USDM and its connection into M11 and UDP.

  • Hugh Glover from Vulcan talked about FHIR and the role of Vulcan in coordinating the various initiatives.

  • Mary Lynn Mercado from TransCelerate (Novartis) sketched out the pathways to implementation.

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Phenotypic Data Exchange for Genomics and Rare Diseases
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21 August

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