When: 23 June 2022
Time: 09:00 - 16:30 (GMT)
Also available as a face to face course, please click here for the face to face 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
Senior Director Regulatory Affairs
Thermo Fisher Scientific Inc
*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.