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:  23 June 2022
Where: Online
Time:  09:00 - 16:30 (GMT)


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:
Stuart Angell Stuart Angell
Director
IVDeology 
Nancy Consterdine
Independent Consultant
IVDeology
Gill Morgan Gill Morgan
Director
Sestria 
Simon Richards  Simon Richards
Vice President, Regulatory Affairs
Abbott 

Steve Lee
Director, Diagnostics Regulations
ABHI
Erin Wigglesworth Erin Wigglesworth
Senior Regulatory Affairs Specialist
Cepheid
                   Colleen Watson 
Senior Director Regulatory Affairs
Thermo Fisher Scientific Inc 

Pricing    

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 meetings@topra.org for a discount code before making your booking.
Those working for regulatory agencies, government agencies or academic institutions 
  
 £270+20%VAT

Those working for charities, patient groups or in full-time education
  £180+20%VAT

*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.
When
23/06/2022
Where
ONLINE
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