When: 5 July 2023
Time: 09:00 - 16:30
Also available as a face to face course, please click here for the online registration option
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
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
CPD: This course provides 6 CPD hours upon successful completion
- 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
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Download the programme HERE
*VAT, if applicable, is charged at VAT of 20%
||£360 + 20% VAT*
A limited number of discounted places are available at the rates below.
Please email us at firstname.lastname@example.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
On-demand webinar: Your Career in Regulatory Affairs - Your First 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.