When: 16-18 June 2025
Where: TOPRA 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: 10:15 BST (CET+1) | Day 3 end time: 16:15 BST (CET+1)
Suitable for
This course is essential for:
- People new to medical devices and in vitro diagnostics (IVDs), usually with 1-2 years’ experience;
- Those who want a broader understanding of medical devices;
- Anyone in medicines regulation who work with drug-device combination products;
- Those working in other areas of regulatory affairs who are looking to move into, has an interest in, or would like a greater understanding of medical devices.
Note: this course is also Module 13 of the MSc Regulatory Affairs.
Course Overview
TOPRA's Introductory Courses have been designed to provide a firm foundation to your career in regulatory affairs. Under the guidance of our medical device regulatory affairs expert speakers, you will emerge a more confident and proactive professional who will be able to:
- Understand and comply with medical device regulations
- Classify medical devices
- Assess borderlines issues
- Establish and maintain an internal audit and supplier audit programme
- Prepare and manage a third-party audit
- Recognise diverse country requirements
- Advise on how to conduct a clinical investigation
- Implement a copy approval process.
Benefits for delegates
Delegates will understand the:
- Role of the essential requirements / harmonised standards and how to demonstrate conformity
- Different conformity assessment routes and how to select the most appropriate route for their product
- Role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure.
- Need for clinical evidence for CE marking
- Needs of payers and how to include these as part of the development of the device regulatory package
- Key elements within a PMS system
- Criteria for vigilance and the Competent Authority (CA) expectations
- Minimum requirements and CA expectations for implementing a Field Safety Corrective Action (FSCA)
- Impact of marketing literature on regulatory status
CPD: This course provides 23 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 the draft programme here.
Module Leader
Presenters
Presenters for this training course include:
-
Peter Bowness, Vice President Quality & Regulatory, International, GE HealthCare
- Howard Dobbs, Principal Consultant, Howard Dobbs Consulting Ltd
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£2,200.00 + VAT* |
Standard Price
Non-member |
£2,600.00 + 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
|
£1,650.00 + VAT* |
Government or academic rates
Non-member
|
£1,950.00 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£1,100.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£1,300.00 + 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.