Agenda eRA
Day 2 | 15 May
Subject to change
Opening Day 2 & Recap Day 1
Martin Schmid, CEO (EXTEDO)
Aligning Documents to Data: Bridging the Gap for Regulatory and Industry - Future Trends and Impacts
Remco Munnik (Deloitte)
Synchronizing eCTD and Track & Trace: Bridging Regulatory Efficiency and Supply Chain Transparency
Podium Discussion: Benefits of Implementing an End-to-End Solution
Networking Coffee Break
Breakout Session
11:00 WHO Prequalification goes eCTD: Getting Products to Those in Need
11:30 FHIR in Focus: Global Status and Industry Impact
12:15 Latest Technology Trends with US FDS Regulatory Affairs and BridgeBio's Readiness Karteek Sandadi (BridgeBio)
Breakout Session
11:00 TBD
11:45 TBD
12:15 TBD
Networking Buffet Lunch
Joint User Group Meeting
Thank you & Closing
Martin Schmid, CEO (EXTEDO)
Networking Coffee Break
User Group Meeting 1
Submission Management Hub Industry (Customers only)
User Group Meeting 2
User Group Meeting Authority (Agencies only)
User Group Meeting 3
Safety Management Hub (Customers only)
User Group Meeting 4
Registration & Document Management Hub powered by CARA (Customers only)
User Group Meeting 5
Exploration Session (Prospects)