2026 Keynotes

Step into the future of clinical operations excellence at CHI's 9th Annual SCOPE Europe! Held in Barcelona, Spain, at the InterContinental Barcelona (Fira Center), this event offers three days packed with insights, new case studies, and networking. With six conferences, attendees will explore the latest trends in clinical trial innovation, planning, and operations. Engage in keynote sessions, panels, and breakout discussions, and visit the exhibit hall featuring 65+ companies showcasing cutting-edge technologies. Connect with over 800 senior executives from 300 organisations across 30 countries. From leading Pharma and Biotech sponsors to global and regional CROs, clinical trial technology providers, academia, sites, and patient advocacy groups, SCOPE Europe brings together leaders in clinical research. Don't miss out on this premier event. Join us and shape the future of clinical operations excellence!

View All 7 Conference Programs | Attendee Profile | Best of Show Award | Conference-at-a-Glance

MONDAY, 12 OCTOBER 2026

Arrive on Monday in beautiful Barcelona and start SCOPE Europe on Monday Afternoon! Visit our Travel page.

*All registered attendees of SCOPE Europe are invited to attend any or all of the workshops. Please RSVP when registering. For a detailed description of each workshop and user group, please Click Here.

13:45 – 15:15 WORKSHOP 1: Fixing Study Start-Up and Recruitment in Europe: Feasibility, Site Selection, and Data-Driven Enrollment Planning (Sponsorship Opportunity Available)

15:00 – 18:00 WORKSHOP 1: Capital & Innovation at SCOPE Europe: Investing in the Next Generation of Clinical Trial Technology and Operations*
NEW THIS YEAR! Click here for additional details and workshop programming.
*Separate registration required

15:30 – 16:45 WORKSHOP 2: AI, Digital Twins and Connected Insights: The Future of Clinical Trials is Here
Reimagining how trials are designed, run, and experienced
INSTRUCTORS:
Sowyma Srinivasan, Principal, ZS
Emilie Tyas, Associate Principal, R&D and Drug Development, ZS
Clinical 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 WORKSHOP 3: ICH E6(R3) in Practice: Redesigning Clinical Trial Execution, Quality, and Oversight (Sponsorship Opportunity Available)

Join friends and colleagues for dinner at a spot near the conference hotel, which is in a great location: /travel

Main Conference Tuesday and Wednesday, 13-14October 2026. Join the morning run/walk at 6:45. Registration opens at 7:45, and the opening presentations start at 8:40.

TUESDAY, 13 OCTOBER 2026

06:45 SCOPE Europe Fun Run

RUN COORDINATOR:
Bridget Kotelly, Senior Conference Director, Cambridge Healthtech Institute
Start your Tuesday with the SCOPE Europe Fun Run! Join fellow attendees for an informal run, jog, or walk at your own pace. Meet in the front lobby near the concierge at 6:45 sharp, and don’t forget your sneakers!

07:45 Registration and Morning Coffee

08:40 – 10:43 Join Conference Sessions (7 Tracks)

10:43 Grand Opening Coffee Break in the Exhibit Hall
The SCOPE Europe Exhibit Hall is the best place to fuel up with a mid-morning coffee while visiting with our many exhibitors. Learn about what’s new in the industry, connect with colleagues and partners, and make some new friends.

11:40 Grab Your Seat: Plenary Keynote Seat Raffle & Prize Giveaway!* (Sponsorship Opportunity Available)
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute
* Must be present to win.

11:45 Organiser's Welcome to SCOPE Europe
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

11:50 KEYNOTE PRESENTATION: Shaping Innovation Pathways in Europe: The Evolving Role of Scientific Advice and Early Regulatory Engagement
Christophe Lahorte, PhD, Head, Innovation Office & Scientific Regulatory Advice Unit, FAMHP (Federal Agency for Medicines and Health Products)
As Europe works to accelerate clinical development, innovation pathways and scientific advice are becoming critical tools for aligning regulators and sponsors earlier in the process. This keynote will explore how these mechanisms are evolving across Member States and at the European level, and how earlier, more structured engagement can reduce uncertainty, improve trial design, and support faster, more efficient development.

12:15 KEYNOTE PANEL: Can Europe Compete for the Future of Clinical Trials? Competitiveness, Regulation, and Investment
PANEL MODERATOR:
James O'Shaughnessy, Senior Partner, Newmarket Strategy; Board Member, Health Data Research UK (HDR UK); former Health Minister, UK Government
As sponsors look to accelerate development timelines, questions are emerging about Europe’s competitiveness as a destination for clinical trials. This panel will examine the structural factors influencing global portfolio decisions, including regulatory frameworks, site capacity, operational efficiency, and investment trends. Senior leaders from industry, policy, and research institutions will discuss what Europe must do to remain a leading hub for clinical innovation.

PANELISTS:

Niklas Blomberg, PhD, Executive Director, Innovative Health Initiative (IHI)

Elena Bolaños, Vice President, Regional Head EMEA GCO, Johnson & Johnson

Christophe Lahorte, PhD, Head, Innovation Office & Scientific Regulatory Advice Unit, FAMHP (Federal Agency for Medicines and Health Products)

Lawrence Tallon, CEO, Medicines and Healthcare Products Regulatory Agency (MHRA)

12:45 KEYNOTE PRESENTATION: FAST-EU & ACT EU in Practice: What’s Actually Accelerating Clinical Trials in Europe…and What Isn’t
Stan Van Belkum, PharmD, General Secretary & CEO, Central Committee on Research Involving Human Subjects (CCMO)
European initiatives like FAST-EU and ACT EU aim to streamline trial approval and execution, but results remain uneven across Member States. This talk will provide a candid, on-the-ground view of what is working, where bottlenecks persist, and what sponsors and regulators must change to deliver faster, more predictable study start-up in Europe.

13:05 KEYNOTE PANEL: Reinventing the Clinical Development Operating Model: New Models for Clinical Execution
PANEL MODERATOR:
Caroline Feys, MSc, MBA, Leader, R&D Operations Innovation, Johnson & Johnson Innovative Medicine
As clinical trials grow more complex and costly, sponsors are rethinking how clinical development organisations are structured and operated. This keynote panel will explore how global pharma and biotech companies are evolving their operating models to streamline execution, improve cross-functional collaboration, and accelerate timelines. Panelists will share real-world examples of organisational transformation, including new approaches to clinical operations, digital enablement, and partnerships with CROs and sites.

PANELISTS:

Tim Horlacher, PhD, Vice President & Head R&D, Strategy & Business Consulting, Bayer AG

Maria Koutsopoulou, Senior Vice President, Head of Global Development Operations, Merck KGaA

Matthieu Ruffin, Vice President, Head of Study Leadership, Novartis

13:35 Join Your Peers for a Networking Luncheon in the Exhibit Hall
Take this opportunity to refresh and refuel with our Exhibit Hall lunch. Enjoy good food and even better conversation during our walk and talk luncheon.

14:35 – 17:00 Join Conference Sessions (7 Tracks)

16:57 Reception in the Exhibit Hall with Beer, Wine, and Tapas
Wind down at the end of a busy session day with colleagues, beer, wine, and tapas. Have a drink with your favorite exhibitor and take a chance at winning a fabulous raffle prize (must be present to win)!

WEDNESDAY, 14 OCTOBER 2026

08:15 Registration and Morning Coffee

08:45 – 10:15 Join Conference Sessions (7 Tracks)

10:25 Coffee Break in the Exhibit Hall
More coffee, more exhibitors, more networking, and some delicious snacks. What’s not to love?

14:25 Organiser's Remarks: Seat Raffle and Prize Giveaway* (Sponsorship Opportunity Available)
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute
*Must be present to win!

14:35 KEYNOTE PRESENTATION: AI-Driven Computational Twins in Clinical Research: Simulating Feasibility, Site Performance, and Trial Operations
Robert McGregor, PhD, Executive Director, AI Program Head, Novartis
AI-driven computational twins are transforming clinical trial operations by simulating feasibility, site performance, enrollment dynamics, and operational risks before study launch. Combining historical and real-time data, these models enable scenario testing, predictive forecasting, and faster operational decisions. This talk explores how AI-powered simulations can improve trial planning, optimize site strategies, reduce delays, and enhance efficiency across clinical research programs.

15:00 KEYNOTE PRESENTATION: When Investigator Sites Choose Sponsors: The Silent Shift Reshaping Clinical Operations
Nick Hodges, Senior Vice President & Head, Clinical Development Operations & R&D Transformation Office, Ipsen
As competition for sites, investigators, and patients intensifies, the traditional sponsor-driven model of trial execution is shifting. Increasingly, high-performing sites are selecting sponsors based on operational efficiency, burden, and partnership quality. This talk will explore how mid- and large pharma organisations are rethinking clinical operations, redefining the role of CRAs, and introducing new functions / enhanced roles to improve site engagement and execution at scale.

15:20 KEYNOTE PANEL: Sites and Sponsors: Reducing Site Burden and Operational Friction

PANEL MODERATOR:
Andrew Ustianowski, MD, Regional Network Director, NIHR Research Delivery Network, UK
For decades, sponsors and clinical sites have shared the same goal—bringing new therapies to patients—yet operational misalignment continues to create friction across the clinical trial ecosystem. This panel will explore how leading organisations are working to reduce site burden, improve patient engagement, and build stronger partnerships between sponsors, research centers, and patient communities. The discussion will highlight practical steps for creating more sustainable and collaborative trial models.