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

This course is 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)
• 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

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

Presenters

	Ashleigh Batchen, Regulatory Strategy Principal, TÜV SÜD
	Stuart Angell, Managing Director, IVDeology
	Tom Beale, Senior Regulatory Affairs Specialist, Agilent Technologies

Pricing    

Standard

• Member: £410 +VAT*
• Non-member: £510 +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 receive 25% discount.
• Those working for charities, patient groups or in full-time education receive 50% discount.

*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

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