This course is also available to attend in-person.
When: 14-16 April 2026
Where: Online
Day 1 start time: 08:30 BST | Day 3 end time: 16:15 BST
CPD: 18 CPD hours upon successful completion
Who should attend
This course is ideal for:
- People new to regulatory affairs who want to acquire a comprehensive foundation
- Regulatory professionals wishing to update their knowledge
- Allied professionals wanting to understand the role of regulatory affairs
- Students of the TOPRA MSc programme
What you'll learn
By completing this course, you will be able to:
- Apply key EU and UK pharmaceutical regulatory guidelines and documentation effectively
in your regulatory work
- Approach complex regulatory affairs issues with practical strategies that support clinical trial and marketing authorisation activities
- Assess incomplete or conflicting regulatory information and present clear, well-reasoned recommendations to colleagues and stakeholders
- Build a strong professional network and engage with experts from regulatory agencies,
industry, and contract organisations
- Strengthen the practical skills and confidence needed to progress your career as a
regulatory affairs professional
Course overview
Understanding the European regulatory landscape is essential for an effective drug development strategy. This course helps regulatory affairs professionals explore the structure and function of regulatory operations in the EU and the UK, focusing on the requirements for clinical trial authorisation and marketing authorisation. Participants will examine key legislative frameworks and the role of regulatory affairs in guiding products from development through to approval.
Course presenters
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 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.