Essentials of In-Vitro Diagnostics Regulatory Affairs

Essentials of In-Vitro Diagnostics Regulatory Affairs
This course will provide a basic, comprehensive grounding in regulatory affairs for IVDs in a relaxed and interactive environment.

: 23 June 2022
Where: TOPRA Office, 6th floor, 3 Harbour Exchange, London, E14 9GE
Time:  09:00 - 16:30 (GMT)

Also available as a virtual course, please click here for the virtual 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.


Download the programme HERE


Stuart Angell Stuart Angell
Nancy Consterdine
Independent Consultant
Gill Morgan Gill Morgan
Simon Richards  Simon Richards
Vice President, Regulatory Affairs

Steve Lee
Director, Diagnostics Regulation
Erin Wigglesworth Erin Wigglesworth
Regulatory Affairs Manager
SPD - Swiss Precision Diagnostics
                     Colleen Watson
Senior Director Regulatory Affairs - 

Thermo Fisher Scientific Inc


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 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

*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.
23/06/2022 10:30 - 17:00
TOPRA Office 6th Floor 3 Harbour Exchange South Quay London E14 9EG UNITED KINGDOM
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