Faculty webinar - Forthcoming changes to clinical trial legislation and approvals processes with Cat Johnston and Gurmel Bhachu

View Cat's presentation

View Gurmel's presentation

Useful links

• Guidance on changes to the clinical trials regulations - Health Research Authority
• Medicines: clinical trials hub - GOV.UK
• The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
• ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf

Webinar description

The new UK Clinical Trial Regulations have been signed into law and will be fully in force, along with the new version of Good Clinical Practice, in April 2026. This represents the biggest overhaul of clinical trial regulations in the last 20 years, streamlining processes and reducing unnecessary burden whilst still ensuring we work to the highest ethical and scientific standards. Whilst these changes are legal requirements for drug studies, they also represent best practice considerations for non-drug studies.

As part of this streamlining, the approvals processes for health and social care research in the UK will also be changing. These changes will make it easier and quicker to set up and run research studies in the UK.

This webinar covers the practical considerations of these regulatory updates as well as giving an overview of the anticipated changes to the approvals process. It was jointly presented by the Health and Care Research Wales GCP Training Manager and the Approvals Manager. 

Speakers

Cat Johnston is the Good Clinical Practice (GCP) Training Manager at Health and Care Research Wales. She manages the research training programme across Wales and works collaboratively with the national Institute for Health and Care Research (NIHR) as part of their GCP Leads group. She is passionate about the impact high quality training can make to research delivery and, ultimately, to the wellbeing and experience of our participants.

Gurmel Bhachu is an Approvals Manager within the NHS at Health and Care Research Wales, where he ensures research studies meet rigorous ethical, legal, and regulatory standards. His expertise lies in navigating the complexities of NHS research governance, with a strong focus on legislative compliance and operational efficiency.

Gurmel brings to the role a well-rounded skill set that includes effective communication, strategic negotiation and a problem-solving mindset - qualities that enable him to facilitate successful research approvals and foster collaboration between researchers, institutions, and regulatory bodies.

One of Gurmel's proudest career achievements was leading the development and successful approval of the governance policy for Marie Curie during his tenure as a Senior Research Governance Manager - an initiative that strengthened research integrity and compliance across the organisation.

Gurmel is committed to advancing high-quality, ethically sound research within healthcare and always open to professional conversations around improving governance practices in the sector.