When: 29 April 2020
Where: ONLINE
Time: 10:30-17:00 (GMT+1)
TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers.
All delegates already booked on the course will be individually contacted and if you require further information please do e-mail meetings@topra.org
Course overview
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
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)
- Those who work in regulatory authorities and those in the regulatory sector
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 latest version of the programme can be downloaded here.
Presenters
Pricing
Course fees:
| Type |
Fee |
| Standard |
£360 + 20% VAT* |
Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
|
Those working for regulatory agencies, government agencies or academic institutions
|
|
Those working for charities, patient groups or in full-time education
|
£180+20%VAT |
|
*VAT, if applicable, is charged at VAT of 20%
Related courses
On-demand webinar: Your Career in Regulatory Affairs - Your First Steps
Next steps
Click here for upcoming CRED-level courses.
Click here for upcoming webinars
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to these terms and conditions.