This course is also available to attend in-person.
When: 3 - 5 March 2026
Where: Online
Day 1 start time: 09:00 GMT | Day 3 end time: 16:15 GMT
CPD: 15 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of drug device combinations and other technologies
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
What you'll learn
By completing this course, you will be able to:
- Develop and recommend effective regulatory and marketing strategies for products manufactured using innovative or non-traditional processes
- Interpret and apply current legislation, directives, and guidance governing medical devices and drug–device combination products
- Make informed judgements on appropriate regulatory strategies for drug–device combinations and borderline products
- Critically evaluate and address issues arising from requirements that extend beyond the core medical device regulations
- Deliver practical, evidence-based solutions to complex regulatory challenges to support successful market access
Course overview
Innovative technologies such as drug–device combinations, borderline products, and devices manufactured using non-traditional processes present unique regulatory and strategic challenges. This course supports regulatory affairs professionals in navigating these complexities by examining relevant legislation, classification, clinical evaluation, and risk management. Participants will explore emerging technologies such as 3D printing, Advanced Therapy Medicinal Products (ATMPs), and tissue engineering, while developing the skills to anticipate regulatory issues, propose compliant strategies, and successfully guide novel products to market.
The course also incorporates case studies and insight from Notified Bodies and Competent Authorities to connect regulatory theory with real-world application.
Course presenters
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* |
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 attendees only where applicable. 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.