This course is also available to attend in-person.
When: 24 - 26 March 2026
Where: Online
Day 1 start time: 13:00 GMT| Day 3 end time: 16:00 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 the U.S. regulatory environment
- 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:
- Demonstrate a critical understanding of the U.S. regulatory environment governing drug development and marketing authorisation
- Interpret and apply FDA regulatory requirements and documentation standards for marketing submissions
- Critically analyse legal documentation and communications from regulatory bodies such as the FDA
- Evaluate current research and regulatory developments to make informed, evidence-based judgements in complex situations
- Communicate regulatory conclusions clearly to both specialist and non-specialist audiences
Course overview
A strong grasp of the U.S. regulatory landscape is essential for professionals working in global drug development. This course equips regulatory affairs professionals with a comprehensive understanding of U.S. regulatory operations, including FDA procedures and submission pathways. Through case-based learning, participants will explore how U.S. regulatory practices influence and integrate with global strategies.
Key topics include:
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* |
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.
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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.