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)
Six Years of National Medicines Verification: Key Learnings for the European Health Data Space & Best Practices for Future Implementations
Martin Zacharias (Arvato Systems)
Podium Discussion: Benefits of Implementing an End-to-End Solution
Dr. Stephan Bedürftig-Weigl (Lyomark Pharma), Lukas Ebertsch (Heumann Pharma), Stavros Kardahakis (EXTEDO)
Networking Coffee Break
Break-Out Session
10:45 WHO Prequalification goes eCTD: Getting Products to Those in Need Antony Fake (WHO)
11:15 FHIR in Focus: Global Status and Industry Impact John Jones (Entitech Solutions)
11:45 Latest Technology Trends in US FDA Regulatory Affairs and BridgeBio’s Readiness Karteeek Sandadi (BridgeBio)
Break-Out Session
10:45 ISDIN's Journey to IDMP Compliance: How MPDmanager Streamlined Regulatory Data Management Carla Ugas (ISDIN)
11:15 TBD
11:45 A Strategic Approach to Optimizing Regulatory Processes at SIFI Stefania Mariani (SIFI)
Networking Buffet Lunch
Joint User Group Meetings
User Group Meeting Agency
13:15 User Group Meeting Agencies only
User Group Meeting Industry
13:15 Joint User Group Meeting Industry
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)