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
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
Christian Spandöck Team Manager, Clinical, R&D Business Consulting
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
Waseem Awad Development Excellence (DevEx) Practice Leader, R&D Business Consulting
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
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
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
Doug Bain Consulting Partner
Arithmos
Lucy-Rowell
Lucy Rowell Consulting Partner
Arithmos
Veronica-Pomo
Veronica Pomo Clinical Operations Excellence Lead
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)

Connect with Clinical Operations Leaders

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