Connecting Leaders To Improve Oversight and Collaboration
18 November, 2025 | Copenhagen, Denmark
Agenda
Wednesday, 18 November, 2025
9:00 a.m. – 5:15 p.m.
9:00 – 9:30 a.m.
Welcome
9:30 – 10:00 a.m.
Opening Remarks: Latest Updates to the Industry Whitepaper on R3 Implications on Study Oversight
A summary of key updates to the industry whitepaper based on insights from the 2025 Veeva R&D and Quality Summit.
Pinar Bérénice Bénet
Senior Director Clinical Strategy
Veeva
Veeva
10:00 – 11:00 a.m.
Facing Forward: Industry Collaboration on ICH E6(R3) Oversight
As the industry prepares for the implementation of ICH E6(R3), how is your organization aligning with its evolving oversight principles? This interactive session is designed to foster open dialogue among peers about real-world challenges, successes, and strategies related to ICH E6(R3) oversight and compliance. Through collaborative discussion, gain clarity on your next steps, benchmark your readiness, and leave with a renewed sense of shared purpose as we collectively navigate this pivotal transformation in clinical research.
Kasper Jakobsen
Vault Clinical Process Manager
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Christian Spandöck
Team Manager, Clinical, R&D Business Consulting
Veeva
Veeva
11:00 – 11:30 a.m.
Networking Break
11:30 – 12:30 p.m.
UCB’s Operating Model Evolution: Strengthening Clinical Oversight through People, Process, and Platform
Hear from UCB on its strategies for adopting different operating models to enhance clinical oversight, deepen site relationships, and expand in-housing of value-added study management functions. Including impacts to People, Process, and Platform.
David Appel
CSM Team Lead
UCB
UCB
Waseem Awad
Development Excellence (DevEx) Practice Leader, R&D Business Consulting
Veeva
Veeva
12:30 – 1:00 p.m.
Trial Decision Assessment and Documentation: Ensuring Alignment with Regulatory Requirements and Inspection Expectations
Discuss the assessment and documentation of appropriate decision making throughout trials in alignment with the latest ICH E6 (R3) guidelines. Explore key business preparation, hear insights on current processes, and learn about current Veeva product initiatives that are supporting Sponsor Oversight.
Florent Lusardi
Senior Product Expert, Clinical Operations
Veeva
Veeva
1:00 – 2:30 p.m.
Networking and Lunch Break
2:30 – 3:30 p.m.
Syneos Streamlining Collaboration: Improving Oversight with Sponsors and CROs
Hear how Syneos proactively supports sponsors with study oversight and ICH E6(R3) compliance, including tips to improve data exchange between sponsors and CROs, and proven best practices to strengthen relationships between study partners.
Madeleine Vorster
Senior Director, Clinical Data Science
Syneos Health
Syneos Health
3:30 – 4:00 p.m.
Networking Break
4:00 – 5:00 p.m.
Arithmos and Chiesi: Insights Into Ensuring Clinical Trial Oversight Through Technology
Explore how the distinct needs of Clinical Operations and Clinical Data shape the requirements for effective oversight governance in light of ICH E6(R3). Delving into the specific challenges and priorities of each domain will highlight the critical role each area has in enabling oversight activities and proof, leveraging fit for purpose oversight systems under a solid governance framework.
Doug Bain
Consulting Partner
Arithmos
Arithmos
Lucy Rowell
Consulting Partner
Arithmos
Arithmos
Veronica Pomo
Clinical Operations Excellence Lead
Chiesi
Chiesi
5:00 – 5:15 p.m.
Closing Remarks
Evening Activities
5:30 – 9:00 p.m.
5:30 – 6:45 p.m.
Visit the Aquarium (Optional)
6:45 – 9:00 p.m.
Networking Dinner (Optional)