Archives: Agenda

• What changes for sponsors when EHDS, eIDAS 2.0 wallets, the Data Governance Act and the AI Act converge on clinical trial data infrastructure.
• Why current consent and audit-trail architectures will not survive a participant’s right to revoke or port their data, and what the Nordic region is already building as the working answer: consent evidence ledgers, privacy-preserving computation, and neutral data altruism intermediaries

• Sharing practical examples of what has worked (and what hasn’t)
• Highlighting key challenges and how to overcome them
• Comparing tools in terms of ease of implementation, cost, and impact for smaller teams
• Exploring which solutions are realistically adoptable within limited resources and existing systems

In recent years, some of the most damaging cyberattacks in Europe share a common thread – identity. As traditional defences strengthen, attackers have shifted tactics, moving away from malware and exploits toward abusing legitimate credentials, permissions, and trust relationships within enterprise environments.

This session considers how attackers use identities to navigate industry-standard defences. We’ll explore the anatomy of an identity-based attack – from initial access through to organisational-wide takeover – and highlight recurring patterns seen across European enterprises.

Today’s breaches aren’t the result of poor security but of unseen complexity. Hidden identity attack paths buried deep in Active Directory and Entra ID provide adversaries with millions of routes to critical systems.

We’ll conclude with a strategy to move from reactive defence to proactive identity risk management. By continuously mapping and removing identity attack paths, organisations can eliminate the bridges adversaries depend on.

• Defining clear roles and responsibilities between sponsor and CRO to avoid duplication and gaps
• Identifying what sponsors should actively oversee versus what can be delegated with confidence
• Setting oversight models that focus on risk rather than excessive monitoring
• Improving communication and escalation pathways to prevent delays and misalignment

• Identifying how clinical strategy and data quality impact investment decisions
• Translating investor expectations into practical changes in trial design and execution
• Applying these insights to improve funding strategy in a tougher market

Update from COMBINE “all-in-one” Pilot Exploring the coordinated assessment of combined study applications

• Learnings and experience from the pilot phase 1
• Framework of the pilot phase 2 and experiences so far