This course is also available to attend in-person.
When: 8-10 September 2026
Where: Online
Day 1 start time: 10:30 BST | Day 3 end time: 16:30 BST
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 biological, biotech and advanced therapy products
- 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:
- Understand the development, unique characteristics, and regulatory strategies for biological, biotechnology, and advanced therapy products
- Navigate regulatory requirements, licensing, clinical trial, and marketing authorisation processes with confidence
- Critically assess regulatory communications, legal documentation, and research publications to inform decision-making
- Apply regulatory principles to complex scenarios and communicate conclusions clearly to both specialist and non-specialist audiences
- Evaluate the impact of production, quality, and clinical changes on biological products, including compatibility considerations
Course overview
Due to their complexity and innovation, biological, biotechnology and ATMPs pose unique regulatory challenges. This course provides attendees with a comprehensive understanding of the scientific and strategic considerations that underpin their development and approval will explore data requirements, quality issues, and licensing procedures specific to these products, including vaccines, monoclonal antibodies and gene therapies. The course enables participants to critically evaluate regulatory frameworks and respond effectively to challenges in this evolving field.
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* |
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.