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

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), Dr. Stavros Kardahakis (EXTEDO)
Networking Coffee Break

Break-Out Session 3

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 Karteek Sandadi (BridgeBio)

Moderated by Andrea Striebel, EXTEDO

Break-Out Session 4

10:45 ISDIN's Journey to IDMP Compliance: How MPDmanager Streamlined Regulatory Data Management Carla Ugas (ISDIN)

11:15 Embracing eCTD 4.0 with a CRO as Your Transition Partner Daniel Langa (ASPHALION)

11:45 A Strategic Approach to Optimizing Regulatory Processes at SIFI Stefania Mariani (SIFI)

Moderated by Ralf-Peter Berg, EXTEDO

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)

End of eRA Conference
View Day 1