Regulation of In Vitro Diagnostic Medical Devices

Regulation of In Vitro Diagnostic Medical Devices
This Masterclass is also Module 19 of the MSc and is primarily focused on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This class is also module 19 of the TOPRA MSc Regulatory Affairs.


When: 12–14 February 2020
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Start time Day 1: 13:00 | End time Day 3: 15:30 GMT

Course overview

The Masterclass will cover both the current regulatory environment and the new regulations as they come into effect and cover:
  • The current EU regulatory environment and a comparison to the regulatory environments in jurisdictions such as Japan, China and Brazil
  • Definitions and classification of IVD devices
  • Conformity Assessment
  • Quality Management Systems
  • Risk management
  • Technical documentation
  • Performance data and product claims
  • Post market surveillance, vigilance and FSCA
  • Other relevant legislation
  • Companion diagnostics and other emerging technologies

This course will enable you to:

  • Demonstrate a critical understanding of the regulatory environment in the EU and other territories and critically evaluate how these compare
  • Critically evaluate the challenges involved in conducting clinical evidence studies using IVD products, giving consideration to the differences between these products and other medical devices in the design and production of clinical data
  • Demonstrate critical understanding of the quality system requirements associated with the manufacture and supply of IVDs
  • Demonstrate critical understanding of the roles of the different stakeholders involved in the manufacture, supply and regulation of IVDs
  • Be able to recommend development strategies for IVD products that will meet global requirements
  • Explain the regulatory requirements for vigilance and post-market surveillance for IVDs and be able to make recommendations about the implementation of a surveillance strategy
  • Explain the regulatory requirements for the development of an IVD medical device and be able to guide the preparation of the IVD technical documentation needed for CE Marking
  • Critically appraise and evaluate communications from regulatory bodies and research publications regarding IVDs
CPD: This course provides 19 CPD hours upon successful completion

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

Programme

The programme will be available closer to the event.

Speakers

TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.

Confirmed speakers for this course:

Additional speakers will be announced closer to the event.

This course is suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of IVD's
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject

Pricing  

    Course fees:
    Type Student Delegate
    Standard    £1500+VAT £1700+VAT 

    Discounted places
    A limited number of discounted places are available  for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT 
    Please email us at meetings@topra.org for a discount code before making your booking.
    Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer
         
         
    • VAT, if applicable, is charged at 20% 
    • The registration fee does not include accommodation 
    • Refreshments and lunch are included in the registration fee
         
         

    Related courses

    Essentials of In-Vitro Diagnostic Regulatory Affairs
    MSc Module 13: Principals of Medial Device Regulatory Affairs

    Next steps

    Module 10: Leadership and Strategic Management in Regulatory Affairs
    Module 12: Data Management and Digitalisation of Medical Devices
    Module 21: US Regulation of Medical Devices     

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions
    When
    12/02/2020 - 14/02/2020
    Where
    TOPRA 6th Floor 3 Harbour Exchange London E14 9GE UNITED KINGDOM
    Online registration not available.
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