When: 13 July 2027
Where: Online
Time: 09:00-16:00 BST
CPD: 6 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Regulatory affairs professionals seeking an introduction to IVD devices
- Professionals in marketing, medical, quality, legal, or related roles working with IVDs
- Employees of regulatory authorities or others in the IVD regulatory sector
What you'll learn
By completing this course, you will be able to:
- Understand the regulatory environment for IVDs and how regulations and controlling documents are applied
- Identify key regulated markets and the main regulatory authorities for IVDs
- Understand the key elements of product performance (General principles of Safety and Performance)
- Learn the principles of labelling and documentation requirements
- Understand the purpose and maintenance of product files
- Gain insight into submissions, certifications, and the approval process
Course overview
This course is designed to help regulatory affairs professionals master the fundamentals of in vitro diagnostics.
It provides a comprehensive overview of the regulatory environment, covering key regulatory processes and issues related to IVDs. The course aims to build confidence in communicating the basics of IVDs within the context of regulatory affairs and grow your career.
Presenters
The expert presenters for this course will be announced soon.
Pricing
TOPRA member: £650 + VAT
Non-member: £910 + VAT
Join TOPRA and enjoy the member rate on every training course you book. Become a member >
Members working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets and MSEs can access further discounted rates. Please email
meetings@topra.org before booking.
Important Notice On VAT
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.