Sponsored Webinar-Understanding the EU CTR

Sponsored Webinar-Understanding the EU CTR
FREE SPONSORED WEBINAR - A comprehensive overview of the EU CTR (Regulation (EU) No 536/2014) now that the transition period has fully ended (January 31, 2025), and its current implications for clinical trial conduct across EU/EEA Member States.

4 September 2025 - 14:00 - 15:00 BST / 15:00 – 16:00 CET
Understanding The Evolving Regulatory Landscape: EU and UK Clinical Trial Regulations in 2025 and Beyond

Understanding the EU Clinical Trial Regulation (CTR): A comprehensive overview of the EU CTR (Regulation (EU) No 536/2014) now that the transition period has fully ended (January 31, 2025), and its current implications for clinical trial conduct across EU/EEA Member States.

* Deep Dive into CTIS: Exploration of the Clinical Trials Information System (CTIS) functionality, recent enhancements (including the revised transparency rules effective June 2024), and best practices for sponsors and authorities interacting with the portal throughout the clinical trial lifecycle.
* Understanding the UK Clinical Trial Regulations: A comprehensive overview of the Medicines for Human Use (Clinical Trials) Regulations 2004, with particular focus on IRAS Combined Review.
* UK Clinical Trial Regulatory Overhaul: Examination of the significant changes to UK clinical trial regulations, including the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 which became law in April 2025 and will take full effect on April 28, 2026. This will cover the motivations behind these reforms, such as streamlining approvals and enhancing patient safety. Discussion of specific changes coming into force in the UK over the next few months, including the implementation of a revised Combined Review process, the new notification scheme for low-risk trials, and updated transparency and archiving requirements.
* Strategic Implications for Industry: Analysis of the complexities and potential impact of these diverging and converging regulatory landscapes in the EU and UK on clinical trial strategy, operations, and future planning for pharmaceutical and medical device companies.

Learning Outcomes
 
Attendees will be able to:
* Differentiate between the current EU Clinical Trial Regulation (CTR) and the evolving UK clinical trial regulatory framework.
* Explain the critical role and practical application of the CTIS portal for clinical trial submissions, assessments, and oversight within the EU.
* Identify the key amendments and upcoming changes to UK clinical trial regulations (effective April 2026) and their anticipated impact.
* Assess the implications of the regulatory changes in both the EU and UK on the design, conduct, and management of their clinical trials.
* Develop informed strategies to navigate the complexities of clinical trial regulations in Europe, ensuring compliance and optimizing efficiency for future research endeavours.

Speaker


Rebecca Tregent, Director of Regulatory Affairs: Rebecca, based in the UK, brings over a decade of experience in Global Regulatory Affairs to the team. Rebecca has an impressive track record in guiding a wide range of therapies and product types through a variety of regulatory pathways. Specifically related to drug development, her expertise includes Phase I-IV Clinical Trials, INDs/NDAs, non-interventional / observational studies, and Expanded Access Programs (EAPs). In addition, she has also been involved in countless early access mechanisms across the globe, including, PIM, ODD and EAMS. Alongside this experience, Rebecca also has experience in Medical Device development, supporting with MDR, IVDR and sAMD requirements across many regions, ranging from products obtaining CE marking, to preparing medical dossiers for combination therapies. Having worked extensively on novel drugs, medical devices, and combination therapies, she offers clients a deep understanding of regulatory strategies and pathways, experience that has been obtained through Rebecca’s unique background as both a clinical trial scientist and within the UK Health Authorities, this experience enables her to bridge perspectives, enhancing success and efficiency for our clients. Throughout her career, Rebecca has been actively involved in developing regulatory strategies to suit client needs and providing a wealth of knowledge to those around her. 

This webinar is sponsored by Arriello



Disclaimer: Whilst TOPRA is running this webinar for Arriello, this is not an endorsement of Arriello, Arriello's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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  • Non-members: free

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When
04/09/2025 14:00 - 15:00
Where
ONLINE
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