When: 3 July 2024
Where: Online
Time: 09:00 - 16:30
Also available as an in-person course, please click here for this registration option.
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
Download the programme HERE
Presenters
Presenters:
Pricing
Standard
- Member: £395 +VAT*
- Non-member: £395 +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: £296.25+VAT*
- Those working for charities, patient groups or in full-time education: £197.50+VAT*
*VAT, if applicable, is charged at 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.