15:00 – 18:00 WORKSHOP 1: Capital & Innovation at SCOPE Europe*
Investing in the Next Generation of Clinical Trial Technology and Operations
INSTRUCTORS:
Moe Alsumidaie, Chief Editor, Editorials, Clinical Trial Vanguard
Niklas Blomberg, PhD, Executive Director, Innovative Health Initiative (IHI)
Maria Koutsopoulou, Senior Vice President, Head of Global Development Operations, Merck KGaA
Christophe Lahorte, PhD, Head, Innovation Office & Scientific Regulatory Advice Unit, FAMHP (Federal Agency for Medicines and Health Products)
Rana Lonnen, Life Sciences and Healthcare Investor
Jean-Christophe Renondin, MD, Managing Partner, Vesalius Biocapital IV
Matthieu Ruffin, Vice President, Head Study Leadership, Novartis
Stephen Scaldaferri, Head Vice President, Global Growth, Thermo Fisher Scientific, Inc.
Lawrence Tallon, CEO, Medicines and Healthcare Products Regulatory Agency (MHRA)
As clinical research across Europe evolves, combining AI-powered decision tools, real-world data, decentralized frameworks, patient-focused engagement, and digital operational model, the demand for coordinated investment and cross-sector partnership continues to intensify.
This workshop gathers venture investors, growth and corporate funds, biotech founders, CRO and site leaders, and clinical-operations executives to examine strategic investment areas, operational barriers, and new partnership pathways supporting next-generation clinical-trial operations and technologies throughout Europe.
Through concentrated discussions, market analysis, and curated networking, attendees will identify priority opportunities for collaboration, evaluate commercial and scaling considerations, and explore partnership approaches that align investors, innovators, CROs, and biopharma stakeholders. Detailed Agenda
*Separate registration required
Arrive on Monday in Beautiful Barcelona and Start SCOPE Europe on Monday Afternoon!
All registered attendees of SCOPE Europe are invited to attend any or all of the workshops. Please RSVP when registering. The new “Capital & Innovation” requires a separate registration. For a detailed description of each workshop and user group, please Click Here. Host Your User Group or a Workshop/Think Tank/Roundtable at SCOPE Europe:
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13:45 – 15:15 OPEN WORKSHOP 2: Fixing Study Start-Up and Recruitment in Europe: Feasibility, Site Selection, and Data-Driven Enrollment Planning (Sponsorship Opportunity Available)
15:30 – 16:45 OPEN WORKSHOP 3: AI, Digital Twins, and Connected Insights: The Future of Clinical Trials is Here
INSTRUCTORS:
Sowyma Srinivasan, Principal, ZS
Emilie Tyas, Associate Principal, R&D and Drug Development, ZS
Reimagining how trials are designed, run, and experiencedClinical development is at a tipping point. After a decade of steady digitisation, the convergence of multimodal data, agentic AI, digital twins, and growing regulatory openness has finally made a fundamentally different operating model possible. Trials are poised to shift from slow, fragmented, and linear to connected, intelligent, and continuous, with meaningful gains in cost, speed, and the probability of success. In this 75-minute interactive workshop, ZS will share a bold vision for the future of clinical trials, grounded in four building blocks: R&D Mission Control, the In Silico Slingshot, the Clinical Trial Biosphere, and Data at the Speed of Light. We will then open the floor for structured dialogue with peers on adoption barriers, talent implications, and the first practical moves clinical development leaders should make now. Join us to pressure-test the future of clinical trials with the people building it.
17:00 – 18:30 OPEN WORKSHOP 4: ICH E6(R3) in Practice: Redesigning Clinical Trial Execution, Quality, and Oversight (Sponsorship Opportunity Available)
MODERATOR:
Madeleine Whitehead, Process Excellence Leader, Product Development Quality Solutions, Roche Products Ltd.
With ICH E6(R3) now in effect, this workshop walks clinical research teams through the practical implications for oversight and quality management. From the rationale behind the revision through investigator oversight and digital compliance expectations, the session translates the new guidance into what it means for monitoring plans, quality management systems, and collaboration between sponsors, study partners, and sites. A case study exercise and open Q&A close out the session, giving attendees a chance to apply the framework to real-world scenarios.
- Ethical foundations and the historical evolution of GCP
- Building quality into protocols with Quality by Design (QbD) and Critical-to-Quality (CtQ) factors
- Tailoring monitoring intensity, data verification, and oversight proportionate to study risks
- Data governance and enforcing ALCOA+ standards
- Understanding the modernized R3 terminology shift
- Investigator oversight and responsibilities under R3 expectations
- Compliance in digital systems and remote consent
- Pragmatic trial execution