This course is also available to attend online.
When: 29 June - 1 July 2026
Where: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Day 1 start time: 13:00 BST| Day 3 end time: 16:30 BST
CPD: 14 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the TOPRA MSc programme
- Delegates from the healthcare regulatory affairs profession who wish to develop their knowledge of the requirements for the clinical evaluation of medical devices
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
- Clinical trial experts who want to understand the regulatory side and work with the regulatory team
What you'll learn
By completing this course, you will be able to:
- Demonstrate a critical understanding of global regulatory frameworks, directives, and documentation relating to clinical evaluation
- Evaluate clinical research methodology and assess the quality and relevance of existing evidence
- Analyse and interpret legal and technical documentation supporting clinical evaluations
- Appraise communications from regulatory bodies and stakeholders to inform evidence-based decisions
- Address complex issues systematically and creatively, making sound judgments and communicating conclusions clearly to both specialist and non-specialist audiences
Course overview
Understanding clinical investigation and evaluation is central to the safe and effective development of medical devices. This course explores the regulatory pathways and alternative routes to compliance in both the EU and U.S. Participants will examine who should conduct clinical evaluations, the types of studies required, and the strategic role of clinical evidence throughout the device lifecycle. Ethical, methodological and global regulatory requirements are addressed, preparing professionals to critically assess clinical strategies for diverse device categories.
Building on these foundations, the masterclass will cover key topics including:
Course presenter
TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,750.00 + VAT* |
Standard Price
Non-member |
£2,450.00 + VAT* |
TOPRA MSc Students
|
£1,750.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to all attendees, regardless of your country of origin. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number, click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.