When: 23-25 July 2025
Where: TOPRA office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: 09:00 BST | Day 3 end time: 16:30 BST
This course is also available to attend online.
Suitable for
This course is essential for:
- Delegates from the pharmaceutical industry who wish to develop their knowledge
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
- Students on the TOPRA MSc programme.
Note: this course is also Module 21 of the MSc Regulatory Affairs.
Course information
This course will cover:
- US FD&C Act and Code of Federal Regulations
- History, Structure and Mission of the FDA
- Product Designation and Device Classification
- Pre-Submissions, Pre-Market Notification & Approval
- Combination Products
- Device Listing and Establishment Registration
- Labelling
- Quality Systems Regulation and Inspections
- Medical Device Reporting
Benefits to delegates
This course will enable you to:
- Understand the global importance of the US medical devices market and the history and context of medical device regulation in the US
- Demonstrate a critical understanding of the US medical devices regulation, processes and procedures
- Critically evaluate the different routes into the US medical device market and the regulatory requirements and processes for each
- Evaluate the differences and similarities between the regulation of medical devices in the US and EU
- Be able to make recommendations about entering the US medical devices market and a suitable strategy for doing so. This will include the ability to apply product jurisdiction, device classification criteria and identify relevant regulatory pathways and requirements
- Make sound judgments in he absence of complete data and communicate their conclusions effectively
- Critically appraise and evaluate communications relating to medical devices from US regulatory bodies and research publications
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 download the draft programme here
Module Leader
Presenters
Further details will be released in the near future.
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.