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