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Pharmaceuticals

EU CTR, UK CTA Reform, and ICH E6(R3): Strategies for Clinical Trial Success in the EU and UK

Thursday, May 7, 2026
14:30 - 15:30 WEST
Location: Auditorium 3
Learning Level: Intermediate
Description: The UK remains one of the most attractive destinations for clinical research, offering sponsors rapid approvals, integrated access to 67 million patients through the NHS, and a deeply interconnected research ecosystem that fosters cross-sector innovation.

With the new UK Clinical Trial Regulations coming into effect in April 2026, the environment is set to become even more sponsor-friendly, introducing risk-proportionate oversight and a streamlined approval process.

This session will unpack the upcoming changes in clinical trial authorisation procedures and compare them with the Combined Review model introduced in 2022, highlighting what sponsors need to know to achieve successful transition. We will share practical insights from supporting initial clinical trial authorisations, managing substantial modifications, and navigating end-of-trial activities as requirements evolve in both the UK and EU.

We also aim to provide early feedback from the MHRA’s Route B pilot, which promises accelerated approvals for amendments. The session will benefit from the participation of MHRA or HRA representatives, offering first-hand regulatory perspectives and guidance.

Learning Objectives:

  • Upon completion, participants will identify the new UK Clinical Trial Regulation requirements and key differences from current UK and EU CTA procedures.
  • Upon completion, participant will be able to understand changes in approval processes and associated timelines under the new framework.
  • Upon completion, participants will be able to interpret updated definitions and submission routes for substantial modifications.
    Upon completion, participants will be able to evaluate future opportunities and strategic advantages for conducting clinical trials in the UK.