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EuroVulcan - March 2023

Conference Agenda - Day 1

9:30 Welcome

  • Opening remarks

Vulcan Overview

  • What is Vulcan? Why is it Needed?
  • What is an HL7 FHIR Accelerator?
  • Impact of FHIR & how this changes the game 

Connectathon Overview

  • What is a FHIR Connectathon?
  • A quick look at some past Vulcan Connectathons 

Vulcan Fundamentals

  • What Vulcan is and is not
  • Where does FHIR fit in the universe of standards such as CDISC, IHE, HL7 v2/v3, OHDSI
  • The Vulcan value proposition 

The Vulcan Project Process

  •  From Idea to Use Case to Project to Standard / Implementation Guide (IG) 

Regulatory Perspectives on FHIR

  •  Strategic view from EMA, FDA and European HMA 

12:30 Lunch

  • All invited to view Connectathon in progress
  • Discussion groups during lunch  

13:30 Implementation Insights / Showcase

  •  FHIR implementations from multiple perspectives - Vendor / Regulator / Pharma / Academic 

Vulcan Implementation Guide Overview

  • What goes into an Implementation Guide? 
  • Content and objectives
  • Quick dive into Vulcan Implementation Guides 

Vulcan Electronic Product Information (ePI) Project

  • ePI project overview
  • Relationship with Gravitate Health
  • ePI Implementation Guide Walkthrough
  • Key points learned 

16:30 Finish

Conference Agenda - Day 2

9:30 Welcome & Connectathon Report

  • Opening Remarks
  • Report back from the 4 tracks of day 1 
  • Forward plans & next steps

HL7 FHIR in Europe

  •  Specific HL7 FHIR-based use cases, projects and initiatives focused on interoperability and clinical research in Europe 

12:30 Lunch

13:15 Vulcan Implementation Strategy

  •  Vulcan Implementation Strategy preview and discussion 

Perspectives on FHIR Implementation

  •  Perspectives from Regulators, Pharma and Government  

Vulcan Engagement in Europe

  •  How to tie some of the efforts in HL7 FHIR in clinical research in Europe into Vulcan?
  • How can these organizations participate in Vulcan?
  • What will Europe activities look like? 

Where To Next?

  • Learnings from today
  • Next steps to continue the dialog to support Vulcan in Europe  

16:00 Finish

Confirmed Speakers

Speakers from EMA, AEMPS, FDA, J&J and others

  

  • Amy Cramer, Vulcan co-Chair, Johnson & Johnson
  • Anne Moen, Gravitate Health, University of Oslo
  • Catherine Chronaki, Gravitate Health, HL7 Europe
  • Craig Anderson, Pfizer
  • Darren Weston, Vulcan co-Chair, Johnson  & Johnson
  • Elizabeth Scanlan, EMA
  • Evinn Dreusys, AEMPS
  • Geoff Low, Medidata/PHUSE
  • Giorgio Cangioli, Gravitate Health, HL7 Italy,  HL7 Europe
  • Hugh Glover, Vulcan Technical Director
  • Jessica Jeffries, IgniteData
  • Jose Galvez, FDA
  • Martin Ingvar, Karolinska Institutet, Sweden
  • Michael van Campen, Vulcan Program Director
  • Mitra Rocca, FDA
  • Peter Casteleyn, Johnson & Johnson
  • Stacy Tegan, Vulcan Strategy Director,  TransCelerate Biopharma

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