Archives: Agenda

• The impact of the new UK clinical trial regulations coming into force in April 2026 and what they mean for sponsors, investigators, and trial delivery
• Government priorities and progress across the UK clinical research ecosystem two years on
• How artificial intelligence is transforming clinical trial design, feasibility, patient identification, and operational efficiency
• Cross-sector collaboration between regulators, industry, and the NHS to strengthen the UK’s position as a leading destination for clinical research
• Looking ahead: building a more agile, technology-enabled clinical trials environment in the UK

• Prioritising evidence that meaningfully advances regulatory and clinical credibility
• Leveraging publications, partnerships and existing data without inflating costs
• Practical tips and insights on structuring FDA interactions and study design to maximise impact with constrained resources

During the roundtable discussion session, the conference hall will be divided into three ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the medical devices industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Hybrid and decentralised execution playbooks aligned to FDA’s decentralised elements guidance

ROUNDTABLE 2
Cybersecurity evidence expectations for connected devices

ROUNDTABLE 3
Improving participation through eligibility and enrolment practices reflecting FDA’s December 2025 guidance

ROUNDTABLE 4
Continuous post-market evidence expectations influenced by MDCG 2025-10

• Choosing when RWD can credibly support device regulatory questions
• Establishing data quality, provenance, and governance requirements
• Designing hybrid evidence packages combining trials and RWE