When: 24 - 26 March 2026
Where: TOPRA Office, 3rd Floor, City Reach, 5 - 6 Greenwich View Place, London, E14 9NN
This course is also available to take part in online
Suitable for
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the US regulatory environment
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
Course information
The purpose of this course is to provide an understanding of the regulatory environment in the US in order to place its global influence in perspective.
Lectures and workshops will cover understanding of US drug development including:
- The history of drug regulation in the US
- The legal basis of regulatory affairs in the US
- Common application types (eg, IND, NDA, BLA, ANDA and SNDA)
- OTC products
- Orphan drugs
- Fast track approvals
- Adverse event reporting
- Labelling
- Advertising and advertising controls
- Communicating with the FDA.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable students to contextualise their understanding and knowledge.
Benefits for delegates
This course will enable you to:
- Posses a systematic understanding of knowledge, and a critical awareness of the regulatory environment and procedures governing regulatory approval of clinical trials in the US and regulatory marketing authorisation in the context of drug development
- Demonstrate a conceptual understanding of the regulatory requirements, FDA requirements, regulatory authorisation and associated documentation for marketing submissions
- Display originality in the application of knowledge of the US regulatory aspects of drug development to evaluate critically current research in the discipline
- Demonstrate the ability to critically analyse the legal documentation for US drug development
- Critically appraise and evaluate communications from regulatory bodies (such as the FDA) and critically evaluate research publications
- Deal with complex issues related to the US regulatory authorisation, both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences.
CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
You can view and download a copy of the draft programme based on previous courses here.
Module Leader(s)
Suitable for
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the US regulatory environment
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,900.00 + VAT* |
Standard Price
Non-member |
£2,375.00 + VAT* |
TOPRA MSc Students
|
£1,650.00 + VAT* |
Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£1,425.00 + VAT* |
Government or academic rates
Non-member
|
£1,781.25 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£950.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£1,187.50 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Please email meetings@topra.org for a discount code before making your booking.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.