Workshop: Understanding the New Clinical Trials Legislation
Thursday 9 October 2025
10:00 - 12:00
This event has now passed, but the On Demand version is available for purchase here.
Join us for an engaging workshop on the new UK clinical trials legislation, hosted by FPM’s Clinical Trial Science and Regulations Expert Group, and chaired by Dr Kirsty Wydenbach FFPM!
From 28 April 2026, new legislation governing the conduct of clinical trials of investigational medicinal products (IMPs) will come into force. These changes will reshape the way clinical trials are designed, approved, and managed in the UK, bringing with them both opportunities and challenges for stakeholders across the research and development landscape.
What will the workshop cover? This interactive workshop will:
- Provide a clear overview of the new legislation and associated guidance, including ethics and GCP changes.
- Explain the key differences compared with the current framework, including practical implications for trial sponsors, investigators, and regulatory teams.
- Explore case studies that bring the legislation to life, examining realistic scenarios that physicians may encounter in their daily work.
- Offer a forum for discussion, where participants can share perspectives and raise questions about implementation.
By combining expert-led presentations with applied case examples, the session will help attendees translate legislative requirements into practical actions and strategies.
Who should attend? This workshop is designed for a broad audience across the FPM community and beyond, including those who simply wish to learn more but are not involved in clinical trials on a daily basis.
Those who may specifically wish to attend are:
- physicians involved in trial design, conduct, or monitoring of clinical trials
- regulatory affairs specialists seeking clarity on compliance and approvals
- pharmaceutical physicians and medical monitors who need to understand how changes will affect their oversight responsibilities.
Who is speaking?
This workshop is being led by members of FPM’s Clinical Trial Science and Regulations Expert Group. Find out more about our experts below.
Event Details
When? Thursday 9 October 2025
Time? 10:00-12:00 (UK time)
Where? Online via Zoom
Price Options
FPM Members £40
Non-Members £80
Reduced Rate* £20
*Reduced rates are available for FPM members who fulfil one of the following criteria: PMST trainees, people from low and lower-middle income countries, unemployed, part-time employed (earning less than £24,000 per year), people on Parental Leave, people who are Out of Practice & Retired.
This event has now passed, but the On Demand version is available for purchase here.
Refunds
The refund policy for the event is as follows:
• For cancellations before 17:00 (UK time) on Wednesday 8 October 2025 a full refund will be given.
• Refunds will not be given for cancellations made after 17:00 (UK time) Wednesday 8 October 2025.
Meet the experts
Dr Kirsty Wydenbach is a regulatory expert and pharmaceutical physician, and since 2022 has been Head of Regulatory Strategy at Weatherden, a global integrated clinical consultancy experienced in de-risking drug development. She also currently chairs the Clinical Trial Science and Regulations Expert Group of the Faculty of Pharmaceutical Medicine (FPM), is a visiting senior lecturer for King’s College London, and sits on the Drug Development Advisory Board at Simbec-Orion.
Prior to joining Weatherden she has over 13 years experience as an Expert Medical Assessor at the MHRA within the Clinical Trials Unit, having a particular interest in ATMPs and first-in-human studies. Other work has included collaboration with industry groups and global regulators regarding adaptive and novel trial designs, including co-authoring several publications. She led the MHRA work on novel trial design for the Life Sciences Industrial Strategy as well as through the MHRA Innovative Licensing and Access Pathway (ILAP).
Kirsty also oversaw the clinical trials work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the Government Vaccine Taskforce.
Dr Frank Gray is an experienced pharmaceutical physician with a clinical background in emergency care, anaesthesia, and intensive care. His experience in pharmaceutical medicine encompasses global clinical development, across all phases of development, and medical affairs. He is an experienced medical leader, having line and matrix leadership experience in multinational environments. Frank currently serves as the SVP of Global Medicines Development for Indivior, a company focused on developing treatments for substance use disorders and other serious mental illnesses.
Dr Austin Smith is a practising pharmaceutical physician and medical oncologist with over 30 years’ international experience in clinical development and oncology. Currently Chief Medical Officer at Oxcia AB, he has held senior leadership and advisory roles across European biotech and pharma. Austin has directed programs from early phase to proof-of-concept, shaping regulatory strategy, trial execution, and investor engagement. His expertise spans radiopharmaceuticals, oncology therapeutics, diagnostics, and modalities. He has also led First-in-Patient studies, integrated biomarker strategies, and supported fundraising across the UK, EU, North America, Australasia, and South Africa.