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.

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:

Ashleigh Batchen
Regulatory Strategy Principal
TÜV SÜD 

Stuart Angell Stuart Angell
Managing Director
IVDeology 


Tom Beale
Senior Regulatory Affairs Specialist
Agilent Technologies
   

 

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.
When
03/07/2024
Where
Online ONLINE
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