Qarad IVDR Conference 2022

  
Practical

  • WHERE? NHOW Brussels hotel

    NHOW Brussels  
    Rue Royale 250
    1210 Brussels
  • WHEN? October 11-13, 2022 (3 full days from 9.00h - 17.30h) 
  • PRICES?

    - €800 for Pre-Conference Workshop (Oct 11)
    - €1000 for Conference Day 1 or 2 (Oct 12 or 13)
    - €1600 for Conference (Oct 12 & 13)
    - €2000 for Pre-Conference Workshop & Conference (Oct 11, 12 & 13)

    All prices are VAT exclusive (VAT not applicable for payments coming from outside of Belgium).

Conference Agenda*

Day 1

  • Regulatory state-of-play: what's new and what's coming?
  • Classification challenges and complex cases
  • The art of risk management and clinical benefit assessment
  • A practical approach on how to meet the various elements of clinical evidence under the IVDR, including scientific validity, state-of-the-art and performance evaluation plans and reports
  • How to set-up and document your clinical performance evaluation studies in compliance with the IVDR?
  • How good design control can help you address regulatory requirements
  • Requirements imposed on IVD devices used in clinical trials
  • Impact of the IVDR on laboratories
  • Challenges and opportunities experienced when complying to the IVDR – an industry perspective
 

Day 2

  • A Notified Body's point of view
  • How to build compliant pre- and post-market documentation?
  • Documentation required for Software under the IVDR
  • How to address PMS and PMPF requirements for both IVDR compliant and legacy devices?
  • Electronic IFUs: what is required and what is the impact on your organisation?
  • EUDAMED: what can and what should you already do?
  • The art of assigning Basic-UDI-DIs and UDI-DIs
  • Best practice on managing the economic operators within your supply chain
  • The Impact of the IVDR on your Quality Management System
  • How to ensure continued access to the UK and Swiss market?
 

*This is a temporary agenda, which is still subject to change.

Register here to join the Qarad IVDR Conference 2022

Are you booking your tickets before July 31, 2022? Good news, you will get get a discount of €200!
Please use the promo code "EARLYBIRD" and enjoy your discount. Be sure to book in time, because the conference seats are limited.

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