When: 11 July 2025
Where: Online
Time: 09:00 - 16:30
This course is also available to take part in-person.
Suitable for
This course is designed for those:
- Regulatory affairs professionals who require an overview of in-vitro diagnostic devices
- Who work in functions allied to in-vitro diagnostic regulatory affairs (such as marketing, medical, quality, packaging and legal)
- From related professions (law, marketing and sales, healthcare, administration, project management)
- Who work in regulatory authorities and those in the regulatory sector.
Course information
This course will provide a basic awareness of the regulatory environment and an appreciation of some of the main regulatory processes and issues including:
- What are regulations and other controlling documents, and how can they be applied to IVDs
- What are the key regulated markets and regulatory bodies for IVDs
- Key elements of product performance (General principles of Safety and Performance)
- What is risk management
- Labelling requirements
- Product files and their maintenance
- Submissions and certificates
Benefits to delegates
- This course will give you the knowledge to understand and communicate the basics of Regulatory Affairs for IVDs with colleagues
- Be taught by experts with extensive practical examples
- Build a network to support the rest of your career
CPD: This course provides 6 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
The draft programme for this course can be downloaded here.
Presenters
Presenters for this training course include:
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£410.00 + VAT* |
Standard Price
Non-member |
£510.00 + 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
|
£307.50 + VAT* |
Government or academic rates
Non-member
|
£382.50 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£205.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£255.00 + 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%.
Related courses
On-demand webinar: Your Career in Regulatory Affairs - Your First Steps
Next steps
Introductory courses in regulatory affairs
Terms and conditions
By booking a place on this course you are agreeing to these terms and conditions.