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 – 10:00 a.m.
Breakfast and Opening Remarks
10:00 – 10:45 a.m.
Industry Panel Discussion: Assessing the Impact of ICH E6(R3) on Clinical Operations
10:45 – 11:15 a.m.
Networking Break
11:15 a.m. – 12:00 p.m.
Biopharma: Decision to In-house eTMF and Enabling CROs in a Sponsor eTMF
12:00 – 1:30 p.m.
Networking and Lunch Break
1:30 – 2:15 p.m.
Biopharma: Optimising Clinical Quality and Oversight for Outsourced Studies
2:15 – 3:00 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.

Ed Fowler
Madeleine Vorster Senior Director, Clinical Data Science
Syneos Health
3:00 – 3:30 p.m.
Networking Break
3:30 – 4:15 p.m.
Biopharma: Improving Data Management Oversight and Efficiency
4:15 – 5:00 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.

Ed Fowler
David Appel CSM Team Lead
UCB
5:00 – 5:15 p.m.
Closing Remarks

Evening Activities

5:30 – 10:00 p.m.
5:30 – 6:30 p.m.
Visit the Aquarium (Optional)
6:30 – 10:00 p.m.
Networking Dinner (Optional)

Connect with Clinical Operations Leaders

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